Removal of needle shield from syringes and automatic injection devices

ABSTRACT

Exemplary embodiments provide a needle shield remover that reliably engages with a distal cap of an automatic injection device and with one or more needle shields coupled to a syringe of the device. When a user removes the distal cap, the needle shield remover reliably removes the needle shields (e.g., a soft needle shield and a rigid needle shield) from the syringe, thereby exposing the injection needle for performing an injection. In an exemplary assembly method, a needle shield remover is engaged to a needle shield coupled to a syringe, prior to insertion of the syringe and needle shield remover assembly into a housing of the device. This exemplary assembly method allows visual inspection, outside the housing of the device, to ensure that the needle shield remover is correctly and reliably engaged to the needle shield before the syringe and needle shield remover assembly is inserted into the housing.

RELATED APPLICATIONS

This application is a continuation of and claims the benefits ofpriority to U.S. Ser. No. 15/094,364 filed on Apr. 8, 2016, which is acontinuation of and claims benefits of priority to U.S. Ser. No.14/253,348, filed on Apr. 15, 2014, which is a continuation of andclaims benefit of priority to U.S. Ser. No. 13/357,508, filed on Jan.24, 2012, which claims the benefit of priority to U.S. ProvisionalPatent Application No. 61/435,467, filed Jan. 24, 2011, the entirecontents of each application are incorporated herein by reference.

BACKGROUND

Automatic injection devices offer an alternative to manually-operatedsyringes for administering therapeutic agents into patients' bodies andallowing patients to self-administer therapeutic agents. Automaticinjection devices may be used to administer medications under emergencyconditions, for example, to administer epinephrine to counteract theeffects of a severe allergic reaction. Automatic injection devices havealso been described for use in administering anti-arrhythmic medicationsand selective thrombolytic agents during a heart attack. See, forexample, U.S. Pat. Nos. 3,910,260; 4,004,577; 4,689,042; 4,755,169; and4,795,433, the entire contents of which are incorporated herein in theirentirety by reference. Various types of automatic injection devices arealso described in, for example, U.S. Pat. Nos. 3,941,130; 4,261,358;5,085,642; 5,092,843; 5,102,393; 5,267,963; 6,149,626; 6,270,479; and6,371,939; and International Patent Publication No. WO/2008/005315, theentire contents of which are incorporated herein in their entirety byreference.

Conventionally, an automatic injection device houses a syringe and, whenoperated, causes the syringe to move forwardly and a needle to projectfrom the housing so that a therapeutic agent contained in the syringe isinjected into a patient's body.

A conventional automatic injection may include one or more needleshields to protect the syringe needle from damage and accidental contactand to maintain sterility of the injection needle. Needle shieldsinclude a soft needle shield that is formed of a flexible material, anda rigid needle shield that is formed of a rigid, inflexible material andthat provide greater mechanical protection to the injection needle.Conventional automatic injection devices may also include a removablecap covering the needle shields to provide mechanical protection for theneedle shields and to facilitate removal of the needle shields before aninjection may be performed.

FIGS. 1A and 1B illustrate an exemplary syringe 100 including asubstantially tubular syringe body 102 for holding a therapeutic agent.FIG. 1A illustrates a side view of the exemplary syringe 100. FIG. 1Billustrates a cross-sectional view of the exemplary syringe 100 bisectedalong the longitudinal axis L. An injection needle may be coupled at adistal end of the syringe body 102. The injection needle may be coveredand protected by a soft needle shield 104 and a rigid needle shield 106that surrounds the soft needle shield 104. One or more apertures 108 maybe provided in a side wall of the rigid needle shield 106 to allow aportion of the soft needle shield 104 to extend through the apertures108. This permits the soft needle shield 104 and the rigid needle shield106 to latch together which, in turn, permits removal of both the softneedle shield 104 and the rigid needle shield 106 when the rigid needleshield 106 is pulled away from the syringe body 102 in the distaldirection (represented by arrow R), thereby exposing the injectionneedle for use in performing an injection. In an exemplary embodiment, aridged portion 110 may be provided in the exterior surface of the rigidneedle shield 106. The ridged portion 110 may include one or morealternating outwardly-projecting ridges interspaced with grooves, andmay thereby provide a region of higher friction contact for removal ofthe rigid needle shield 106 from the syringe.

SUMMARY

Exemplary embodiments provide a needle shield remover that reliablyengages with a distal cap of an automatic injection device and with oneor more needle shields coupled to a syringe of the device. An exemplaryneedle shield remover includes one or more inwardly-projecting shieldengagement mechanisms that reliably engage with the needle shields, andone or more cap engagement mechanisms that reliably engage with thedistal cap. When a user removes the distal cap, the needle shieldremover reliably removes the needle shields (e.g., a soft needle shieldand a rigid needle shield) from the syringe, thereby exposing theinjection needle for performing an injection. In an exemplary assemblymethod, an exemplary needle shield remover is engaged to a needle shieldcoupled to a syringe, prior to insertion of the syringe and needleshield remover assembly into a housing of the automatic injectiondevice. This exemplary assembly method allows visual inspection, outsidethe housing of the device, to ensure that the needle shield remover iscorrectly and reliably engaged to the needle shield before the syringeand needle shield remover assembly is inserted into the housing.

In accordance with one exemplary embodiment, an apparatus is providedfor removing a needle shield from a syringe. The apparatus includes atubular member for enclosing the needle shield coupled to the syringe.The apparatus also includes one or more cap engagement mechanismsprovided at a distal end of the tubular member and configured forengagement with a distal cap provided for covering a distal end of thesyringe. The apparatus also includes one or more shield engagementmechanisms provided at a proximal end of the tubular member andconfigured for engagement with the needle shield. When the apparatus ispulled away from the syringe, the one or more shield engagementmechanisms exert force against the needle shield to remove the needleshield from the syringe.

In accordance with another exemplary embodiment, an automatic injectiondevice is provided. The automatic injection device includes a syringe, aneedle shield coupled to a distal end of the syringe, and a distal capfor covering the needle shield. The automatic injection device alsoincludes a needle shield remover disposed between the needle shield andthe distal cap. The needle shield includes a tubular member forenclosing the needle shield coupled to the syringe, one or more capengagement mechanisms provided at a distal end of the tubular member andengaged with the distal cap, and one or more shield engagementmechanisms provided at a proximal end of the tubular member and engagedwith the needle shield. When the needle shield remover is pulled awayfrom the syringe, the one or more shield engagement mechanisms exertforce against the needle shield to remove the needle shield from thesyringe.

In accordance with another exemplary embodiment, a method is providedfor assembling an automatic injection device. The method includescoupling a needle shield to a distal end of a syringe. The method alsoincludes engaging one or more shield engagement mechanisms of a needleshield remover to the needle shield. The method further includesinserting an assembly comprising the syringe, the needle shield and theneedle shield remover into a housing of the automatic injection device.

BRIEF DESCRIPTION TO THE DRAWINGS

The foregoing and other objects, aspects, features, and advantages ofexemplary embodiments will become more apparent and may be betterunderstood by referring to the following description taken inconjunction with the accompanying drawings, in which:

FIG. 1A illustrates a side view of an exemplary syringe.

FIG. 1B illustrates a cross-sectional view of the exemplary syringe ofFIG. 1A bisected along the longitudinal axis L.

FIG. 2A illustrates a side view of an exemplary needle shield removerengaged to a syringe.

FIG. 2B illustrates another side view of the exemplary needle shieldremover of FIG. 2A rotated by about 90 degrees.

FIG. 2C illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIGS. 2A and 2B engaged to a syringe and adistal cap.

FIG. 2D is a bottom view of the exemplary distal cap of FIG. 2C showingengagement of the needle shield remover to the distal cap.

FIG. 3A illustrates a perspective view of an exemplary syringe sleeve.

FIG. 3B illustrates a cross-sectional perspective view of the exemplarysyringe sleeve of FIG. 3A bisected along a longitudinal axis L.

FIG. 4A illustrates a perspective view of an assembly of an exemplarysyringe sleeve housing an exemplary syringe that is fitted with anexemplary needle shield remover.

FIG. 4B illustrates a transverse cross-sectional view of the exemplaryassembly of FIG. 4A.

FIG. 5A illustrates a perspective view of an exemplary needle shieldremover.

FIG. 5B illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIG. 5A bisected along a longitudinal axis L.

FIG. 6 illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIGS. 5A and 5B assembled with a syringe and adistal cap.

FIG. 7 illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIGS. 5A and 5B assembled with a syringe, adistal cap and a syringe sleeve.

FIG. 8 illustrates a front cross-sectional view of the exemplaryassembly of FIG. 7.

FIG. 9 illustrates a bottom view of an exemplary distal cap that isapplicable to FIGS. 6-8.

FIG. 10A illustrates a perspective view of an exemplary needle shieldremover.

FIG. 10B illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIG. 10A bisected along a longitudinal axis L.

FIG. 11 illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIGS. 10A and 10B assembled with a syringe anda distal cap.

FIG. 12 illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIGS. 10A and 10B assembled with a syringe, adistal cap and a syringe sleeve.

FIG. 13 illustrates a front cross-sectional view of the exemplaryassembly of FIG. 12.

FIG. 14 illustrates a bottom view of an exemplary distal cap that isapplicable to FIGS. 11-13.

FIG. 15A illustrates a perspective view of an exemplary needle shieldremover.

FIG. 15B illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIG. 15A bisected along a longitudinal axis L.

FIG. 16 illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIGS. 15A and 15B assembled with a syringe anda distal cap.

FIG. 17 illustrates a cross-sectional perspective view of the exemplaryneedle shield remover of FIGS. 15A and 15B assembled with a syringe, adistal cap and a syringe sleeve.

FIG. 18 illustrates a front cross-sectional view of the exemplaryassembly of FIG. 17.

FIG. 19 illustrates a bottom view of an exemplary distal cap that isapplicable to FIGS. 16-18.

FIG. 20 illustrates a cross-sectional view of another exemplary needleshield remover bisected along the longitudinal axis L.

FIG. 21 illustrates a cross-sectional view of another exemplary needleshield remover bisected along the longitudinal axis L.

FIG. 22 illustrates a cross-sectional view of another exemplary needleshield remover bisected along the longitudinal axis L.

FIG. 23 illustrates a cross-sectional view of another exemplary needleshield remover bisected along the longitudinal axis L.

FIG. 24 illustrates a cross-sectional view of another exemplary needleshield remover bisected along the longitudinal axis L.

FIG. 25 is a flowchart of an exemplary method for assembling anexemplary needle shield remover with a syringe and a distal cap of anautomatic injection device, in which the needle shield remover isassembled with a syringe prior to insertion of the syringe into thehousing of the device.

FIG. 26 illustrates a device view of the exemplary method of FIG. 25 bywhich an exemplary automatic injection device may be assembled.

FIG. 27 is a flowchart of an exemplary method for assembling anexemplary needle shield remover with a syringe and a distal cap of anautomatic injection device, in which the needle shield remover isassembled with a syringe after insertion of the syringe into the housingof the device.

FIG. 28 is a flowchart of an exemplary method for using an exemplaryautomatic injection device to administer an injection.

DETAILED DESCRIPTION

One difficulty in the design of conventional automatic injection deviceslies in providing a mechanism that reliably engages a soft needle shieldand/or a rigid needle shield to remove it from the syringe. For example,in certain conventional automatic injection devices, a removable distalcap includes a mechanism that snaps into position in a gap formedbetween the syringe body and the needle shield. When the removabledistal cap is removed, the mechanism in the cap allows the needle shieldto be removed as well because of its engagement with the cap. However,due to component tolerances and other component variations that ariseduring the manufacturing process, it is difficult to achieve, in aconventional automatic injection device, a needle shield removalmechanism that consistently fits within the gap formed between thesyringe body and the needle shield. For the same reasons, it isdifficult to ensure, in a conventional automatic injection device, thatthe needle shield removal mechanism is maintained in engagement with theneedle shield, and that the needle shield removal mechanism applies anappropriate level of force to the needle shield when the user removesthe cap in order to remove the needle shield.

Exemplary embodiments address the deficiencies in conventional automaticinjection devices by providing a needle shield remover that reliablyengages and removes one or more needle shields when a removable distalcap is removed from a distal end of the device. An exemplary needleshield remover may be provided separately from one or more needleshields and from a removable distal cap covering the distal end of thedevice. The needle shield remover may include one or moreinwardly-projecting shield engagement mechanisms that reliably engagewith one or more needle shields, and one or more cap engagementmechanisms that reliably engage with the removable distal cap. When auser removes the removable distal cap covering the distal end of thedevice, the exemplary needle shield remover reliably removes the needleshields from the syringe, thereby exposing the injection needle forperforming an injection.

U.S. Provisional Patent Application No. 61/435,467, filed Jan. 24, 2011,to which the present application claims priority, teaches some exemplaryneedle shield removers that employ the concept of “float” relative to aremovable distal cap and a needle shield remover attached thereto priorto placement of the removable distal cap onto an automatic injectiondevice. U.S. Provisional Patent Application No. 61/435,467, filed Jan.24, 2011, also teaches some exemplary needle shield removers that are“floatless” and do not employ the concept of “float” relative to aremovable distal cap and a needle shield remover attached to anautomatic injection device.

The concept of “float” refers to the structure, function and operationof a needle shield remover and a removable distal cap that form a singleassembly and, as part of the assembly, slide relative to each otheralong a longitudinal axis during attachment to an automatic injectiondevice, where the relative movement exceeds acceptable tolerances thataccount for manufacturing variations in the assembled components. Theemployment of “float” refers to a single assembly formed of a needleshield remover and a removable distal cap that are pre-assembled beforethe needle shield remover is engaged to a needle shield. That is, in anautomatic injection device that employs “float,” the pre-assembledremovable distal cap and needle shield remover form a one-piece assemblythat is engaged to the needle shield and the automatic injection deviceafter the syringe is loaded into the automatic injection device. Thepre-assembled removable distal cap and needle shield remover are engagedto the automatic injection device in at least two steps in which thedistal cap is first engaged to the automatic injection device, andsubsequently the needle shield remover is engaged to the needle shieldby sliding along a longitudinal axis from a first position to an secondengaged position while the distal cap remains engaged to the automaticinjection device.

Other exemplary needle shield removers and distal caps taught in thepresent application are “floatless” and do not rely on the concept of“float” for correctly and reliably assembling a needle shield removerand a removable distal cap in an automatic injection device. The conceptof “floatless” or “floatlessness” refers to the structure, function andoperation of an exemplary needle shield remover and a removable distalcap that are not pre-assembled as a single assembly and that are notconfigured to slide relative to each other along a longitudinal axisduring attachment to an automatic injection device in order to engagethe needle shield remover to the needle shield, where the relativemovement exceeds acceptable tolerances that account for manufacturingvariations in the assembled components. That is, in an automaticinjection device that does not employ “float” (i.e., “floatless”) theremovable distal cap and the exemplary needle shield remover are notpre-assembled and do not form a one-piece assembly. That is, inexemplary “floatless” embodiments an exemplary needle shield remover isan assembly engaged to a needle shield attached to a syringe prior toinsertion of the syringe and needle shield remover assembly into ahousing of the automatic injection device. In turn, the removable distalcap is then engaged to the device in a one-step process in whichcoupling the distal cap to the distal end of the device housing alsoengages the distal cap with the needle shield remover. The structure,function and operation of the removable distal cap and the needle shieldremover in “floatless” embodiments do not accommodate pre-assembly as aone piece assembly and do not accommodate movement of the needle shieldremover attached to the removable distal cap from a first position to anengaged position along a longitudinal axis.

Automatic injection devices that do not rely on the concept of “float”to assemble an exemplary needle shield remover and a distal cap areadvantageous over automatic injection devices that rely on the “float”concept. This is because reliance on the relative movement between theneedle shield remover and the distal cap in automatic injection devicesthat use “float” increases the risk of unreliable and incorrectengagement of the needle shield remover with the needle shield, andthereby reduces robustness of the assembly.

Furthermore, the ability, in exemplary embodiments, to assemble theexemplary needle shield remover with the needle shield outside thedevice housing and outside the distal cap allows visual inspection ofthe assembly process to ensure that the needle shield remover iscorrectly and reliably engaged with a gap between the syringe body andthe needle shield.

I. DEFINITIONS

Certain terms are defined in this section to facilitate understanding ofexemplary embodiments.

The terms “automatic injection device” and “autoinjector,” as usedherein, refer to a device that enables a patient to self-administer atherapeutically effective dose of a therapeutic agent, wherein thedevice differs from a conventional syringe by the inclusion of amechanism for automatically delivering the therapeutic agent to thepatient by injection when the mechanism is engaged.

The terms “vessel” and “container,” as used herein, refer to a syringeor cartridge that may be used in an exemplary automatic injection devicefor holding a dose of a therapeutic agent.

The terms “syringe” and “cartridge,” as used herein, refer to a sterilebarrel portion of an automatic injection device that is filled with adose of a therapeutic agent prior to distribution or sale of the deviceto a patient or other non-medical professional for administration of thetherapeutic agent to a patient. In an exemplary embodiment, a distal endof the barrel portion of a syringe may be coupled to a sterilehypodermic injection needle. In an exemplary embodiment, a distal end ofthe barrel portion of a cartridge may not be coupled to an injectionneedle. That is, in exemplary embodiments, a syringe may be a cartridgewith a pre-attached injection needle coupled to its barrel portion.

Exemplary embodiments described herein with reference to a syringeassembly may also be implemented using a cartridge assembly. Similarly,exemplary embodiments described herein with reference to a cartridgeassembly may also be implemented using a syringe assembly.

The term “pre-filled syringe,” as used herein, refers to a syringe thatis filled with a therapeutic agent immediately prior to administrationof the therapeutic agent to a patient, and a syringe that is filled witha therapeutic agent and stored in this pre-filled form for a period oftime before administration of the therapeutic agent to a patient.

The terms “injection needle” and “needle,” as used herein, refer to aneedle in an automatic injection device that is inserted into apatient's body to deliver a dose of a therapeutic agent into thepatient's body. In an exemplary embodiment, the injection needle may bedirectly coupled to or may otherwise be in contact with a syringeassembly or a cartridge assembly that holds a dose of the therapeuticagent. In another exemplary embodiment, the injection needle may beindirectly coupled to the syringe or cartridge assembly, for example,via a syringe needle and/or a transfer mechanism that provides fluidcommunication between the syringe or cartridge assembly and theinjection needle.

The term “thermoplastic material,” as used herein, refers to a materialthat has the property of softening or fusing when heated and ofhardening and becoming rigid again when cooled. Thermoplastic materialscan be re-melted and cooled repeatedly without undergoing anyappreciable chemical change. A thermoplastic is a polymer that turns toa liquid when heated and freezes to a very glassy state when cooledsufficiently. Most thermoplastics are high-molecular-weight polymerswhose chains associate through weak Van der Waals forces (polyethylene);stronger dipole-dipole interactions and hydrogen bonding (nylon); oreven stacking of aromatic rings (polystyrene). Thermoplastic polymersdiffer from thermosetting polymers (vulcanized rubber) as they can,unlike thermosetting polymers, be re-melted and re-molded. Manythermoplastic materials are addition polymers; e.g., vinyl chain-growthpolymers such as polyethylene and polypropylene.

The term “pre-injection state,” as used herein, refers to a state of anautomatic injection device prior to activation of the device, i.e.,prior to the start of delivery of a therapeutic agent contained in thedevice.

The term “injection state,” as used herein, refers to one or more statesof an automatic injection device during the delivery of a therapeuticagent contained in the device.

The term “post-injection state,” as used herein, refers to completion ofdelivery of a therapeutically effective dose of a therapeutic agentcontained in the device, or removal of the device from the patient priorto completion of delivery of a therapeutically effective dose of thetherapeutic agent.

The term “patient” or “user,” as used herein, refers to any type ofanimal, human or non-human, that may be administered a substance usingexemplary automatic injection devices.

The term “proximal,” as used herein, refers to a portion, end orcomponent of an exemplary automatic injection device that is farthestfrom an injection site on a patient's body when the device is heldagainst the patient for an injection or for mimicking an injection.

The term “distal,” as used herein, refers to a portion, end or componentof an exemplary automatic injection device that is closest to aninjection site on a patient's body when the device is held against thepatient for an injection or for mimicking an injection.

The term “planar” is used herein, in a broad lay sense, to mean exactlyplanar or approximately planar within some tolerance from the exactlyplanar.

The term “concave” is used herein, in a broad lay sense, to mean exactlyconcave or approximately concave within some tolerance from the exactlyconcave.

The term “convex” is used herein, in a broad lay sense, to mean exactlyconvex or approximately convex within some tolerance from the exactlyconvex.

The term “elliptical” is used herein, in a broad lay sense, to meanexactly elliptical or approximately elliptical within some tolerancefrom the exactly elliptical.

The term “oval” is used herein, in a broad lay sense, to mean exactlyoval or approximately oval within some tolerance from the exactly oval.

The term “rectangular” is used herein, in a broad lay sense, to meanexactly rectangular or approximately rectangular within some tolerancefrom the exactly rectangular.

The term “parallel” is used herein, in a broad lay sense, to meanexactly parallel or approximately parallel within some tolerance fromthe exactly parallel.

The term “straight” is used herein, in a broad lay sense, to meanexactly straight or approximately straight within some tolerance fromthe exactly straight.

The term “equal” is used herein, in a broad lay sense, to mean exactlyequal or approximately equal within some tolerance.

The term “adjacent” is used herein, in a broad lay sense, to meanimmediately adjacent or approximately adjacent within some tolerance.

The term “transverse axis” is used herein to refer to an axissubstantially perpendicular to a longitudinal axis.

The term “inwardly-projecting” is used herein to refer to one or moretabs or teeth on a needle shield remover extending length wise along alongitudinal axis and having a proximal end attached to a tubularstructure of the needle shield remover and a distal end detached fromthe tubular structure of the needle shield remover and projectinginwardly into an inner cavity of the tubular structure.

II. EXEMPLARY NEEDLE SHIELD REMOVERS

In an exemplary embodiment, a needle shield remover may be provided as aseparate component from a needle shield for covering an injection needleand from a removable distal cap for covering a distal end of anautomatic injection device. The needle shield remover may include one ormore cap engagement mechanisms configured for engagement with theremovable distal cap so that removal of the distal cap from the devicehousing automatically removes the needle shield remover as well. Theneedle shield remover may include one or more inwardly-projecting shieldengagement mechanisms configured for directly or indirect engagementwith a rigid needle shield (in a device that includes a rigid needleshield) and/or a soft needle shield (in a device that includes a softneedle shield but lacks a rigid needle shield). Since the needle shieldremover is engaged to the needle shield, when the needle shield removeris removed from the device housing (e.g., by removal of the distal capengaged to the needle shield remover), this results in the removal ofthe needle shield engaged to the needle shield remover.

Exemplary needle shield removers are configured and designed for quick,easy and reliable engagement to both the distal cap and to a needleshield. One or more exemplary methods may be used to assemble anexemplary needle shield remover to a needle shield coupled to a syringe.In an exemplary method, an exemplary needle shield remover may beassembled with a needle shield coupled to a syringe after the syringehas been inserted into the housing of the device. In another exemplarymethod, an exemplary needle shield remover—that is provided as aseparate component from a distal cap and a syringe—may be assembled witha needle shield coupled to a syringe prior to insertion of the syringeinto the housing of the device. The ability to assemble the needleshield remover to the needle shield outside the device housing allowsvisual inspection of the assembly process to ensure that the needleshield remover reliably engages the needle shield on the syringe beforethe syringe assembly is inserted into the device housing. Thus, assemblyof the exemplary needle shield remover in the automatic injection deviceallows one to be certain that, when the syringe assembly is insertedinto the device housing, the needle shield remover is engaged reliablyand correctly with the needle shield, thereby resolving the issue ofunreliable positioning of needle shield removal mechanisms inconventional automatic injection devices.

FIGS. 2A-2D illustrate an exemplary needle shield remover 200 engaged toa syringe 202 and to a distal cap 204. FIG. 2A illustrates a side viewof an exemplary needle shield remover engaged to a syringe. FIG. 2Billustrates another side view of the exemplary needle shield remover ofFIG. 2A rotated by about 90 degrees. FIG. 2C illustrates across-sectional perspective view of the exemplary needle shield removerof FIGS. 2A and 2B engaged to a syringe and a distal cap. FIG. 2D is abottom view of the exemplary distal cap of FIG. 2C showing engagement ofthe needle shield remover to the distal cap. The length of an exemplaryneedle shield remover 200 may range from about 10 mm to about 50 mm, butis not limited to this exemplary range.

FIGS. 2A-2D are presented for the purpose of generally describing thestructure, function and operation of an exemplary needle shield remover.Certain specific but non-limiting exemplary embodiments of needle shieldremovers are described in connection with FIGS. 5-24.

In the exemplary embodiment of FIGS. 2A-2D, an injection needle (notpictured) is coupled to the distal end of the syringe 202. The needle iscovered with a soft needle shield 206 that is, in turn, positionedwithin and covered by a rigid needle shield 208. Portions of the softneedle shield 206 may extend through one or more apertures in the rigidneedle shield 208 as shown in FIG. 2B. The exemplary needle shieldremover 200 is positioned over the rigid needle shield 208. The needleshield remover 200 may be used to remove all of the needle shields whenthe needle shield remover 200 is removed from its engagement to thesyringe 202.

The exemplary needle shield remover 200 may include a single tubularmember. In other exemplary embodiments, the needle shield remover 200may include two, three or more tubular members. In the exemplaryembodiment illustrated in FIGS. 2A-2D, the exemplary needle shieldremover 200 may include a proximal tubular member 210 that, at itsdistal edge, is integrally coupled to a distal tubular member 212 insome exemplary embodiments. The distal tubular member 212 may have asmaller outer diameter and a shorter length than the proximal tubularmember 210, and may extend along a shorter length of the needle shieldremover 200 along the longitudinal axis L than the proximal tubularmember 210. A transition portion 214 may extend between the proximaltubular member 210 and the distal tubular member 212. An exemplarytransition portion 214 may be a stepped transition, a ramped transition,or a combination of both.

The distal tubular member 212 may be substantially cylindrical in shapewith a substantially circular or oval cross-section. At its distal end,the side wall of the distal tubular member 212 may include one or moreplatform structures that project longitudinally from the face of thedistal tubular member 212 toward a removable distal cap. In an exemplaryembodiment, a platform structure may include a firstlongitudinally-projecting portion 216 a, a secondlongitudinally-projecting portion 216 b, and a transverse portion 216 cthat extends between the longitudinally-projecting portions 216 a, 216 bat a distal end of the platform structure. The transverse portion 216 cmay support one or more cap engagement mechanisms in one exemplaryembodiment.

At its distal end, an exemplary platform structure may support or defineor provide one or more cap engagement mechanisms 218 a, 218 b thatproject radially outwardly from the platform structure. Exemplary capengagement mechanisms may take the form of protrusions, teeth, clips,and other suitable engagement mechanisms. Exemplary cap engagementmechanisms 218 a, 218 b may have any suitable dimensions and structure.Exemplary lengths of the cap engagement mechanisms may include, but arenot limited to, about 1, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9,3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4, 4.1, 4.2, 4.3, 4.4,4.5, 4.6, 4.7, 4.8, 4.9, 5, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9,6, 6.5, 7 mm, all intermediate numbers, and the like.

In the exemplary embodiment illustrated in FIGS. 2A and 2B, a first capengagement mechanism 218 a and a second cap engagement mechanism 218 bare provided at opposite sides of the platform structure, i.e.,separated from each other by about 180 degrees. In the exemplaryembodiment illustrated in FIGS. 2A and 2B, the cap engagement mechanismsare provided separately and spaced from each other. In another exemplaryembodiment, a single cap engagement mechanism may be provided to extendin an annular manner around the platform structure. One of ordinaryskill in the art will recognize that exemplary needle shield removersmay include any suitable number of cap engagement mechanisms extendingfrom the platform structure including, but not limited to, one, two,three, four, five, six, seven, and the like.

A first end of each cap engagement mechanism 218 a, 218 b may be coupledto or may be provided integrally with the platform structure, and asecond end of each cap engagement mechanism 218 a, 218 b may besuspended over a corresponding gap 220 a, 220 b between the second endof the cap engagement mechanism and the distal tubular member 212.During assembly of the needle shield remover 200 with a removable distalcap 204, provided to cover the needle shield remover, the cap engagementmechanisms 218 a, 218 b may be coupled to the cap 204 so that removal ofthe cap also automatically removes the needle shield remover 200.

FIG. 2C illustrates a cross-sectional perspective view of the removabledistal cap 204 in which a central aperture 226 is provided alonglongitudinal axis L. FIG. 2D is a bottom view of a distal face 222 ofthe distal cap 204 showing engagement of the needle shield remover 200to the distal cap 204. One or more inwardly-projecting stop portions 228a, 228 b (e.g., flanges or raised edges) may be provided at the interiorsurface of the central aperture 226 of the distal cap 204. In theexemplary embodiment of FIGS. 2C and 2D, the inwardly-projecting stopportions 228 a, 228 b may not extend along the entire periphery of thecentral aperture 226. In another exemplary embodiment, theinwardly-projecting stop portions may extend along the entire peripheryof the central aperture 226.

As shown in FIG. 2C, the one or more cap engagement mechanisms 218 a,218 b of the needle shield remover 200 may be made to fit through theaperture 226 of the distal cap 204. In this assembled configuration ofthe needle shield remover 200 and the distal cap 204,inwardly-projecting stop portions 228 a, 228 b (e.g., flanges or raisededges) provided in the aperture 226 of the distal cap 204 may bepositioned reliably within the gap 220 a, 220 b of the needle shieldremover 200. This allows the needle shield remover 200 to be reliablyengaged to the distal cap 204 upon assembly and during removal of thecap 204 from the device housing, thus causing removal of the distal cap204 from the device housing to automatically remove the needle shieldremover 200 as well. Since the needle shield remover 200 is reliablyengaged to one or more needle shields 206, 208, removal of the needleshield remover, in turn, automatically removes the needle shields aswell.

The cap engagement mechanisms 218 a, 218 b may snap into place in theaperture 226 of the distal cap 204 so that the inwardly-projecting stopportions 228 a, 228 b are positioned within the gap 220 a, 220 b of theneedle shield remover 200. In an exemplary embodiment, when the capengagement mechanisms 218 a, 218 b are engaged with the distal cap 204,there may be a decrease in the force experienced against insertion ofthe distal cap 204 over the needle shield remover 200. In an exemplaryembodiment, this decrease in the force may be sensed by a user orautomatically by an assembly machine to determine that theinwardly-projecting stop portions 228 a, 228 b of the distal cap 204have been reliably positioned within the gap 220 a, 220 b of the needleshield remover 200. In an exemplary embodiment, when the cap engagementmechanisms 218 a, 218 b are engaged with the distal cap 204, an audible“click” sound may be emitted to provide an audible indication that thedistal cap 204 has been successfully engaged with the needle shieldremover 200.

The proximal tubular member 210 of the needle shield remover 200 may besubstantially cylindrical in shape with a substantially circular or ovalcross-section. The side wall of the first tubular member 210 may encloseand define a substantially cylindrical cavity for housing the injectionneedle covered by the soft needle shield 206 and the rigid needle shield208.

At or near its proximal edge, the side wall of the proximal tubularmember 210 may define and/or include one or more inwardly-projectingshield engagement mechanisms 230 a, 230 b that are biased by the sidewall to reliably remain positioned within a gap 232 formed between thebody of the syringe 202 and the proximal edge of the rigid needle shield208. In the exemplary embodiment of FIGS. 2A and 2B, a firstinwardly-projecting shield engagement mechanism 230 a and a secondinwardly-projecting shield engagement mechanism 230 b are provided atopposite sides of the needle shield remover 200, i.e., separated fromeach other by about 180 degrees.

The inwardly-projecting shield engagement mechanisms 230 a, 230 b may bepositioned in the gap 232 during the assembly process and may reliablybe positioned in the gap during the use of the device. When theremovable distal cap covering the injection needle is removed beforeperforming an injection (by pulling in the direction indicated by arrowR), the inwardly-projecting shield engagement mechanisms 230 a, 230 bexert force in the direction R against the peripheral edge of the rigidneedle shield 208, thereby pulling the rigid needle shield 208 and thesoft needle shield 206 away from the syringe body 202 in the direction Rand exposing the injection needle for performing an injection.

Exemplary inwardly-projecting shield engagement mechanisms 230 a, 230 bmay be configured to bias against the gap 232 with a sufficient force toensure that when the needle shield remover is removed from the device,the needle shield remover 200 remains engaged with the rigid needleshield 208 and thereby reliably removes the rigid needle shield 208 fromthe body of the syringe 202. Exemplary inwardly-projecting shieldengagement mechanisms 230 a, 230 b may be configured to interface withthe gap 232 over a sufficient area or width to apply a sufficient forceto remove the rigid needle shield when the needle shield remover ispulled away from the syringe. In exemplary embodiments, a width of anexemplary inwardly-projecting shield engagement mechanism 230 a, 230 bthat interfaces with the gap 232 may range from about 3 mm to about 7mm, but is not limited to this exemplary range. In an exemplaryembodiment, the edge of the inwardly-projecting shield engagementmechanisms 230 a, 230 b that interfaces with the gap 232 may besubstantially straight. In another exemplary embodiment, the edge of theinwardly-projecting shield engagement mechanisms 230 a, 230 b thatinterfaces with the gap 232 may be serrated.

In an exemplary embodiment, the inner diameter of the needle shieldremover 200 at the inwardly-projecting shield engagement mechanisms 230a, 230 b may be less than the outer diameter of the rigid needle shield208. The inner diameter of the needle shield remover 200 at theinwardly-projecting shield engagement mechanisms 230 a, 230 b may alsobe less than the outer diameter of the syringe body 202. The innerdiameter of the needle shield remover 200 at the inwardly-projectingshield engagement mechanisms 230 a, 230 b may be substantially equal tothe outer diameter of the gap 232 formed between the syringe body andthe proximal end of the rigid needle shield 208. This configuration ofthe inwardly-projecting shield engagement mechanisms 230 a, 230 b allowsthe shield engagement mechanisms to snap into place at the gap 232 in areliable and tight manner so that disengagement requires a minimalthreshold level of force. This configuration also prevents creep of theinwardly-projecting shield engagement mechanisms 230 a, 230 b out of thegap 232 before the needle shield remover 200 is pulled away from thesyringe body.

An exemplary inner diameter of the needle shield remover 200 may rangefrom about 5 mm to about 20 mm, but is not limited to this exemplaryrange. An exemplary inner diameter of the needle shield remover 200 mayrange from about 8 mm to about 11 mm in some exemplary embodiments. Anexemplary inner diameter of the needle shield remover 200 may be about8.5 mm in an exemplary embodiment. An exemplary inner diameter of theneedle shield remover 200 may be about 11 mm in another exemplaryembodiment.

The inwardly-projecting shield engagement mechanisms 230 a, 230 b maysnap into place at the gap 232 as the needle shield remover 200 isinserted over the rigid needle shield 208. When the inwardly-projectingshield engagement mechanisms 230 a, 230 b snap into place at the gap232, there may be a decrease in the force experienced against insertionof the needle shield remover 200 over the rigid needle shield 208. In anexemplary embodiment, this decrease in the force may be sensed by a useror automatically by an assembly machine to determine that theinwardly-projecting shield engagement mechanisms 230 a, 230 b have beensuccessfully engaged to the gap 232. In an exemplary embodiment, thepositioning of the inwardly-projecting shield engagement mechanisms 230a, 230 b in the gap 232 may emit an audible “click” sound that providesan audible indication that the needle shield remover 200 has beensuccessfully engaged with the rigid needle shield 208.

One of ordinary skill in the art will recognize that exemplary needleshield removers may include any suitable number of inwardly-projectingshield engagement mechanisms 230 a, 230 b including, but not limited to,one, two, three, four, five, six, seven, and the like. Exemplaryinwardly-projecting shield engagement mechanisms may take the form ofprotrusions, teeth, clips, and other suitable engagement mechanisms.

In the exemplary embodiment illustrated in FIGS. 2A and 2B, the one ormore inwardly-projecting shield engagement mechanisms 230 a, 230 b areconfigured and positioned to consistently and reliably fit within thegap 232 formed between the body of the syringe 202 and the proximal edgeof the rigid needle shield 208. In another exemplary embodiment, one ormore inwardly-projecting shield engagement mechanisms 230 a, 230 b maybe configured and positioned to consistently and reliably engage with anaperture in the rigid needle shield 208 (for example, exemplary aperture108 illustrated in FIG. 1A). This allows automatic removal of the rigidneedle shield 208 (and an associated soft needle shield 206) by theinwardly-projecting shield engagement mechanisms 230 a, 230 b of theneedle shield remover 200, when the needle shield remover 200 is removedfrom the device housing by its engagement with a distal cap 204 that isremoved by a user.

In another exemplary embodiment, one or more inwardly-projecting shieldengagement mechanisms 230 a, 230 b may be configured and positioned toconsistently and reliably engage with a ridged portion in the rigidneedle shield 208 (for example, exemplary ridged portion 110 illustratedin FIG. 1A). This allows automatic removal of the rigid needle shield208 (and an associated soft needle shield 206) by theinwardly-projecting shield engagement mechanisms 230 a, 230 b of theneedle shield remover 200, when the needle shield remover 200 is removedfrom the device housing by engagement of the needle shield remover 200with a distal cap 204 that is removed by a user. In another exemplaryembodiment in which the injection needle is covered by a soft needleshield 206 and lacks a rigid needle shield 208, one or moreinwardly-projecting shield engagement mechanisms 230 a, 230 b of theneedle shield remover 200 may be configured and positioned toconsistently and reliably engage with the soft needle shield 206. One ofordinary skill in the art will recognize that the inwardly-projectingshield engagement mechanisms 230 a, 230 b may be configured andpositioned to engage any other suitable component on the rigid needleshield 208 and/or the soft needle shield 206.

In the exemplary embodiment illustrated in FIGS. 2A and 2B, theinwardly-projecting shield engagement mechanisms 230 a, 230 b areprovided in a component separate from the rigid needle shield 208 (i.e.,in the needle shield remover 200), and the shield engagement mechanisms230 a, 230 b are not permanently engaged with the rigid needle shield208. In another exemplary embodiment, the inwardly-projecting shieldengagement mechanisms 230 a, 230 b of the needle shield remover 200 maybe permanently engaged with the rigid needle shield 208, for example,using glue or epoxy.

At or near its proximal edge, the side wall of the proximal tubularmember 210 of the needle shield remover 200 may also define one or morecutout portions 234 for allowing a user to view the contents of thesyringe 202 and/or to view an end-of-injection indicator from outsidethe device housing. That is, the cutout portions 234 of the proximaltubular member 210 may align with a transparent inspection window orinspection aperture provided in the device housing to allow a user toview the contents of the syringe 202 and/or to view an end-of-injectionindicator from outside the device. In an exemplary embodiment, twoexemplary cutout portions may be provided at opposite sides of theneedle shield remover 200, i.e., separated from each other by about 180degrees. In an exemplary embodiment, the cutout portions 234 may beprovided in an alternating manner with the inwardly-projecting shieldengagement mechanisms 230 a, 230 b, all of which may be provided at ornear the proximal edge of the proximal tubular member 210. In anexemplary embodiment, each cutout portion 234 may have a substantiallyconcave shape or a semicircular shape, but is not limited to theseexemplary shapes.

An exemplary width of the cutout portions may range from about 3 mm toabout 7 mm, but is not limited to this exemplary range. Exemplary widthsof the cutout portions may include, but are not limited to, about 4.0,4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4,5.5, 5.6, 5.7, 5.8, 5.9, 6.0 mm, and the like.

One or more additional protrusions and/or grooves may be provided in theexterior surface of the proximal tubular member 210 and/or the distaltubular member 212 in order to facilitate engagement of the needleshield remover 200 with another component of the automatic injectiondevice, e.g., a syringe sleeve that cooperatively engages with andcovers a proximal portion of the needle shield remover 200, a removablecap 204 that covers a distal portion of the needle shield remover 200,and the like. For example, one or more longitudinally-extending grooves236 a, 236 b may be provided in the exterior surface of the needleshield remover 200 to movably engage with a syringe sleeve. In anexemplary embodiment, the syringe sleeve may allow relative movement ofthe syringe sleeve and/or the needle shield remover 200 along thelongitudinal axis L, but may hold the needle shield remover 200 in asubstantially fixed axial orientation relative to the syringe sleeve.This ensures that the cutout portions 234 of the needle shield remover200 are maintained in alignment with a transparent inspection window orinspection aperture provided in the syringe sleeve and with atransparent inspection window or inspection aperture provided in thedevice housing, thus allowing a user to view the contents of the syringe202 and/or to view an end-of-injection indicator through the inspectionwindows or apertures. Certain exemplary embodiments of syringe sleevesare described in connection with FIGS. 3 and 4.

In the exemplary embodiment illustrated in FIGS. 2A-2C, the needleshield remover 200 may be provided as a separate component from thedistal cap 204 of the automatic injection device. In another exemplaryembodiment, a needle shield remover 200 may be provided integrally withthe distal cap 204, for example, by integrally coupling the capengagement mechanisms 218 a, 218 b of the needle shield remover 200 withthe distal cap 204 of the device.

III. EXEMPLARY SYRINGE SLEEVES FOR USE IN AUTOMATIC INJECTION DEVICES

An exemplary automatic injection device may include a syringe sleevethat is a structural member for enveloping a portion of a syringe fittedwith a needle shield remover. The syringe sleeve may be configured tohold and guide the syringe fitted with a needle shield remover, so thatthe syringe may move forwardly within and relative to the housing of thedevice from a retracted position (i.e., farther away from the injectionsite) to an injection position (i.e., closer to the injection site inwhich the injection needle projects from an open end of the devicehousing). The syringe may rest within the syringe sleeve, and both maybe housed within the housing of the automatic injection device.

Other exemplary automatic injection devices may not provide a syringesleeve.

An exemplary syringe sleeve may include a transparent inspection windowor inspection aperture that may be aligned with both a cutout portion ofthe needle shield remover and an inspection window or inspectionaperture provided the device housing, so that the contents of thesyringe may be reliably viewed from outside the device housing. Thesyringe sleeve may maintain the needle shield remover in a substantiallyfixed axial orientation so that the cutout portion of the needle shieldremover is aligned with the inspection window or inspection aperture ofthe syringe sleeve and the device housing. This ensures that movement ofthe needle shield remover within the device does not lead to obscurationof the inspection window or inspection aperture of the device housing.

The syringe sleeve may have any suitable configuration, shape and sizesuitable for accommodating the syringe fitted with the needle shieldremover, and for axially orienting the cutout portion of the needleshield remover in alignment with the inspection window or inspectionaperture of the device housing. The syringe sleeve may be formed of anysuitable material including, but not limited to, thermoplastic polymers,e.g., polycarbonates.

FIG. 3A illustrates a perspective view of an exemplary syringe sleeve300. FIG. 3B illustrates a cross-sectional perspective view of theexemplary syringe sleeve 300 bisected along a longitudinal axis L. Theexemplary syringe sleeve 300 may include a tubular member 302 that maybe substantially cylindrical in shape with a substantially circular oroval cross-section. The side wall of the tubular member 302 may encloseand define a substantially cylindrical cavity for housing a syringefitted with a needle shield remover.

The side wall of the tubular member 302 may define and/or include one ormore transparent inspection windows or inspection apertures 304 forallowing a user of the device to view the contents of the syringe and/oran indicator. The inspection window or inspection aperture of thetubular member 302 may be aligned with the cutout portion of the needleshield remover and with the inspection window or inspection aperture ofthe automatic injection device housing to provide a clear unobstructedview of the syringe contents and/or an indicator. The inspection windowor inspection aperture 304 may have any suitable configuration, size andshape for allowing viewing of the contents of the syringe. Exemplaryshapes of the inspection window or inspection aperture 304 may include,but are not limited to, a substantially elongated oval or ellipticalshape, a substantially elongated rectangular shape, and the like. In anexemplary embodiment, the inspection window or inspection aperture 304may have a longer length along the longitudinal axis L than a widthalong a transverse axis.

In an exemplary embodiment, the entire syringe sleeve 300 may be formedof a transparent material. In another exemplary embodiment, theinspection window or inspection aperture 304 may be the only componentof the syringe sleeve 300 that is formed of a transparent material or isan aperture in the tubular member 302.

An exterior surface of the tubular member 302 may include one or moreraised structures and/or grooves to engage with one or more othercomponents of the automatic injection device. An exemplary raisedstructure may be one or more longitudinally-extending rails 306, 308that may fit movably along internal longitudinally-extending groovesand/or protrusions (not pictured) provided on an interior surface of thedevice housing. The rails 306, 308 may allow the syringe sleeve 300 tomove longitudinally relative to the device housing, and may allow thesyringe sleeve 300 to be held in a fixed axial orientation relative tothe device housing. In an exemplary embodiment, the rails 306, 308 mayextend along the entire length of the tubular member 302. In exemplaryembodiments, one, two, three, four, five, six rails may be provided inthe exterior surface of the tubular member 302, but the number of railsis not limited to these exemplary numbers. Exemplary lengths of therails 306, 308 or grooves and/or protrusions in the exterior surface ofthe tubular member 302 may range from about 1 mm to about 6 mm, but arenot limited to this exemplary range.

An interior surface of the tubular member 302 may include one or moreraised structures and/or grooves to engage with one or more othercomponents of the automatic injection device. An exemplary raisedstructure may be one or more longitudinally-extending rails 310 that mayfit movably along internal longitudinally-extending grooves and/orprotrusions provided on an exterior surface of a needle shield remover.The rails 310 may allow the syringe sleeve 300 to move longitudinallyrelative to the needle shield remover and to allow the needle shieldremover to move longitudinally relative to the syringe sleeve 300. Therails 310 may also allow the needle shield remover to be held in a fixedaxial orientation relative to the syringe sleeve 300. The fixed axialorientation between the needle shield remover and the syringe sleeve 300allows the cutout portion of the needle shield remover to be alignedwith the inspection window or inspection aperture of the syringe sleeve300 and with the inspection window or inspection aperture of the devicehousing. This ensures that the contents of the syringe may be reliablyviewed at any time from the outside of the device through the inspectionwindow or inspection aperture in the device housing. Exemplary lengthsof the rails 310 or grooves on the interior surface of the tubularmember 302 may range from about 1 mm to about 6 mm, but are not limitedto this exemplary range.

A proximal portion of the tubular member 302 (farthest from theinjection site) may be coupled to one or more longitudinally-extendingsyringe alignment guides 311, 312, 314, 316 for aligning a syringe in asubstantially fixed axial orientation relative to the syringe sleeve300. This ensures that the inspection window or inspection aperture 304of the tubular member 302 is reliably aligned with a correspondingcutout portion of an exemplary needle shield remover attached to thesyringe. One of ordinary skill in the art will recognize that any numberof syringe alignment guides may be used in exemplary syringe sleeves.

In an exemplary embodiment, two pairs of syringe alignment guides may beprovided so that the pairs are provided on opposite sides of the tubularmember 302. In an exemplary embodiment, a first pair of guides mayinclude a first syringe alignment guide 311 and a second syringealignment guide 312. A second pair of guides may be provided on anopposite side of the tubular member 302 (i.e., offset from the firstpair of guides by about 180 degrees), and may include a third syringealignment guide 314 and a fourth syringe alignment guide 316.

At a proximal end of the alignment guides, the alignment guides 311 and312 may be coupled to each other by a first beam 318 extending along atransverse axis between the alignment guides 311 and 312. In anexemplary embodiment, a tabbed foot 320 may extend outwardly from thefirst beam 318 to engage with the device housing. At a distal end of thealignment guides, the alignment guides 311 and 312 may be coupledtogether by a second flexible beam 322 extending along a transverse axisbetween the alignment guides 311 and 312. In an exemplary embodiment,the second flexible beam 322 may provide a stopping position for theproximal end of the syringe. That is, when a flanged proximal end of thesyringe reaches the second flexible beam 322, the syringe may beprevented from farther movement toward the injection site as it hasalready achieved its injection position.

Similarly, at a proximal end of the alignment guides, the alignmentguides 314 and 316 may be coupled to each other by a first beam 324extending along a transverse axis between the alignment guides 314 and316. In an exemplary embodiment, a tabbed foot 326 may extend outwardlyfrom the first beam 324 to engage with the device housing. At a distalend of the alignment guides, the alignment guides 314 and 316 may becoupled together by a second flexible beam 328 extending along atransverse axis between the alignment guides 314 and 316. In anexemplary embodiment, the second flexible beam 328 may provide astopping position for the proximal end of the syringe. That is, when aflanged proximal end of the syringe reaches the second flexible beam328, the syringe may be prevented from farther movement toward theinjection site as it has already achieved its injection position.

FIG. 4A illustrates a perspective view of an assembly of an exemplarysyringe sleeve 300 housing an exemplary syringe 400 that is fitted withan exemplary needle shield remover 200 at its distal end. The syringealignment guides 311, 312, 314, 316 provided at the proximal portion ofthe syringe sleeve 300 may align the syringe 400 and hold it in asubstantially fixed axial orientation relative to the syringe sleeve300. As shown in FIG. 4A, the needle shield remover 200 and the syringesleeve 300 overlap each other at some portions, such that the inspectionwindow or inspection aperture 304 of the syringe sleeve 300 overlaps andis aligned with a cutout portion of the needle shield remover 200.

FIG. 4B illustrates a transverse cross-sectional view of an exemplaryassembly in which an exemplary syringe sleeve 300 that houses anexemplary syringe 400 fitted with an exemplary needle shield remover200. The exemplary syringe sleeve 300 includes four exemplarylongitudinally-extending rails 402, 404, 406, 408 on an interior surfaceof the exemplary syringe sleeve 300. The syringe sleeve 300 partiallyencloses an exemplary needle shield remover 200 including fourcorresponding longitudinal grooves 410, 412, 414, 416, respectively.Each rail of the syringe sleeve 300 may engage with a correspondinggroove of the needle shield remover 200, so that the needle shieldremover 200 is held in a substantially fixed axial orientation relativeto the syringe sleeve 300.

Exemplary components illustrated in FIGS. 4A and 4B that are common tothe components illustrated in FIGS. 3A and 3B are described inconnection with FIGS. 3A and 3B.

One of ordinary skill in the art will recognize that syringe sleevesother than the exemplary syringe sleeve illustrated in FIGS. 3A, 3B, 4Aand 4B may be used in exemplary automatic injection devices.

IV. FIRST NON-LIMITING EXEMPLARY EMBODIMENT OF A NEEDLE SHIELD REMOVER

FIGS. 5A and 5B illustrate an exemplary needle shield remover 500 havingtwo exemplary inwardly-projecting shield engagement mechanisms forengagement with a rigid needle shield. FIG. 5A illustrates a perspectiveview of the exemplary needle shield remover 500. FIG. 5B illustrates across-sectional perspective view of the exemplary needle shield remover500 of FIG. 5A bisected along a longitudinal axis L.

The exemplary needle shield remover 500 may include a proximal tubularmember 502 that, at its distal edge, is integrally coupled to a distaltubular member 504 in some exemplary embodiments. The distal tubularmember 504 may have a smaller diameter and a shorter length than theproximal tubular member 502, and may extend along a shorter length ofthe needle shield remover 500 along the longitudinal axis L than theproximal tubular member 502. A transition portion 506 may extend betweenthe proximal tubular member 502 and the distal tubular member 504. Anexemplary transition portion 506 may be a stepped transition, a rampedtransition, or a combination of both.

The distal tubular member 504 of the needle shield remover 500 may besubstantially cylindrical in shape with a substantially circular or ovalcross-section. At its distal end, the side wall of the distal tubularmember 504 may include one or more platform structures that projectlongitudinally from the face of the distal tubular member 504 toward aremovable distal cap. In an exemplary embodiment, a platform structuremay include a first longitudinally-projecting portion 508 a, a secondlongitudinally-projecting portion 508 b, and a transverse portion 508 cthat extends between the longitudinally-projecting portions 508 a, 508 bat a distal end of the platform structure. The transverse portion 508 cmay support one or more cap engagement mechanisms in one exemplaryembodiment.

At its distal end, an exemplary platform structure may support or defineor provide a first outwardly-projecting flexible cap engagementmechanism 510 a and a second outwardly-projecting flexible capengagement mechanism 510 b that project radially outwardly from theplatform structure. Exemplary cap engagement mechanisms may be anysuitable protrusion, projection, teeth, and the like. In the exemplaryembodiment of FIGS. 5A and 5B, the cap engagement mechanisms 510 a, 510b are provided at opposite sides of the platform structure, i.e.,separated from each other by about 180 degrees. One of ordinary skill inthe art will recognize that exemplary needle shield removers may includeany suitable number of cap engagement mechanisms extending from theplatform structure including, but not limited to, one, two, three, four,five, six, seven, and the like.

A first end of each cap engagement mechanisms 510 a, 510 b may becoupled to or may be provided integrally with the platform structure,and a second end of each cap engagement mechanism 510 a, 510 b may besuspended over a gap 512 a, 512 b between the cap engagement mechanisms510 a, 510 b and the distal tubular member 504. During assembly of theneedle shield remover 500 with a distal cap of the automatic injectiondevice (not pictured) provided to cover the needle shield remover, thecap engagement mechanisms 510 a, 510 b may be coupled to the distal capso that removal of the cap also automatically removes the needle shieldremover 500. In an exemplary embodiment, the cap engagement mechanisms510 a, 510 b of the needle shield remover 500 may be inserted to fitwithin a central aperture provided in the distal cap such that one ormore inwardly-projecting stop portions (e.g., flanges or raised edges)provided in the central aperture of the distal cap reliably engage thegaps 512 a, 512 b of the needle shield remover 500. This engagementallows the needle shield remover 500 to be reliably engaged to thedistal cap after assembly and during removal of the distal cap from thedevice housing, thus causing removal of the distal cap from the devicehousing to automatically remove the needle shield remover 500 as well.Since the needle shield remover 500 is reliably engaged to one or moreneedle shields, removal of the needle shield remover, in turn,automatically removes the needle shields coupled to a syringe.

In the exemplary embodiment illustrated in FIGS. 5A and 5B, the needleshield remover 500 may be provided as a separate component from a distalcap of the automatic injection device. In another exemplary embodiment,a needle shield remover may be provided integrally with the distal cap,for example, by integrally coupling the cap engagement mechanisms 510 a,510 b of the needle shield remover 500 with the distal cap of thedevice.

The proximal tubular member 502 of the needle shield remover 500 may besubstantially cylindrical in shape with a substantially circular or ovalcross-section. The side wall of the proximal tubular member 502 mayenclose and define a substantially cylindrical cavity 514 for housingthe injection needle covered by a soft needle shield and/or a rigidneedle shield coupled to a syringe.

At or near its proximal edge, the side wall of the proximal tubularmember 502 may define and/or include a first inwardly-projecting shieldengagement mechanisms 516 a and a second inwardly-projecting shieldengagement mechanism 516 b. The first and second inwardly-projectingshield engagement mechanisms 516 a, 516 b may be biased by the side wallto reliably remain positioned within a gap formed between the body of asyringe and the proximal edge of a rigid needle shield. Exemplaryinwardly-projecting shield engagement mechanisms 516 a, 516 b may be anysuitable protrusion, projection, teeth, and the like. In the exemplaryembodiment of FIGS. 5A and 5B, the exemplary inwardly-projecting shieldengagement mechanisms 516 a, 516 b are provided at opposite sides of theneedle shield remover 500, i.e., separated from each other by about 180degrees. The inwardly-projecting shield engagement mechanisms 516 a, 516b may be positioned in a gap formed between a syringe body and a rigidneedle shield during the assembly process, and may reliably bepositioned in the gap during the use of the device. When a distal capcovering the injection needle is removed before performing an injection(by pulling in the direction indicated by arrow R), theinwardly-projecting shield engagement mechanisms 516 a, 516 b exertforce in the direction R against the peripheral edge of the rigid needleshield, thereby pulling the rigid needle shield and the soft needleshield away from the syringe body in the direction R and exposing theinjection needle for performing an injection.

In an exemplary configuration, each inwardly-projecting shieldengagement mechanisms 516 a, 516 b may be situated at an aperture 518 a,518 b in the proximal tubular member 502. Each inwardly-projectingshield engagement mechanisms 516 a, 516 b may include a first inclinedor radial wall 520 a, 520 b that extends from a proximal base wall ofthe aperture 518 a, 518 b and projects inwardly into the cavity 514 at afirst angle relative to the longitudinal axis L. The first inclined orradial wall 520 a, 520 b may be coupled to or may be integrally formedwith an inwardly-projecting second inclined or radial wall 522 a, 522 b.The second inclined or radial wall 522 a, 522 b may extend from thefirst inclined or radial wall inwardly into the cavity 514 at a secondangle relative to the longitudinal axis L.

In an exemplary embodiment, the second angle corresponding to the secondinclined or radial wall 522 a, 522 b may be substantially greater thanthe first angle corresponding to the first inclined or radial wall 520a, 520 b, so that the first inclined or radial wall 520 a, 520 b extendssubstantially along the longitudinal axis L and the second inclined orradial wall 522 a, 522 b extends substantially orthogonally to thelongitudinal axis L. An exemplary first angle may range from about 0degree to about 20 degrees relative to the longitudinal axis L towardthe cavity 514. An exemplary second angle may range from about 30degrees to about 60 degrees relative to the longitudinal axis L towardthe cavity 514.

Providing the shield engagement mechanisms 516 a, 516 b as part of theproximal tubular member 502 facilitates robust assembly of the needleshield remover 500 in the automatic injection device. Projection of theinclined or radial walls of the shield engagement mechanisms 516 a, 516b from the proximal base wall of the aperture 518 a, 518 b inwardly intothe cavity 514 also facilitates robust assembly of the needle shieldremover 500 in the device. These structural features, for example, allowthe inclined or radial walls of the needle shield remover 500 to moveradially outwardly with respect to the proximal tubular member 502,while minimizing a radially outward movement of the proximal tubularmember 502 at the shield engagement mechanisms 516 a, 516 b, as theneedle shield remover 500 is inserted coaxially over a needle shieldduring assembly. That is, expansion of the outer diameter of the needleshield remover 500 is minimized during assembly in order to minimize therisk of the shield engagement mechanisms 516 a, 516 b not beingpositioned at the gap between the needle shield and the syringe body andto minimize the risk of the shield engagement mechanisms 516 a, 516 bfrom becoming disengaged from the gap between the needle shield and thesyringe body.

Certain conventional needle shield removers include shield engagementmechanisms that are not formed as a part of a tubular member. Inaddition, in certain conventional needle shield removers, the shieldengagement mechanisms do not extend from a proximal base edge of anaperture or support mechanism. These conventional needle shield removersdo not minimize a radially outward movement needle shield removers atthe shield engagement mechanisms. This radially outward movement of theconventional needle shield removers reduces the robustness of theassembly process as it increases the risk of positioning the shieldengagement mechanisms outside a gap formed between the syringe body andthe needle shield.

Exemplary first and second inclined or radial walls may have anysuitable dimension and structure. Exemplary lengths and widths of thefirst and second inclined or radial walls may include, but are notlimited to, about 1, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3,3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4, 4.1, 4.2, 4.3, 4.4, 4.5,4.6, 4.7, 4.8, 4.9, 5, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6,6.5, 7 mm, all intermediate numbers, and the like.

The second inclined or radial walls 522 a, 522 b of theinwardly-projecting shield engagement mechanisms 516 a, 516 b may beconfigured to be positioned within a gap formed between a syringe bodyand a proximal edge of a rigid needle shield. Each second inclined orradial wall 522 a, 522 b may have a peripheral edge 524 a, 524 b with awidth that provides a sufficiently large interface with the rigid needleshield. In exemplary embodiments, the width of the peripheral edge 524a, 524 b may range from about 3 mm to about 7 mm, but is not limited tothis exemplary range. In an exemplary embodiment, the width is about4.00 mm.

In an exemplary embodiment, the inwardly-projecting first and secondinclined or radial walls 520 a, 520 b, 522 a, 522 b cause the innerdiameter of the needle shield remover 500 at the inwardly-projectingshield engagement mechanisms 516 a, 516 b to be less than the outerdiameter of the proximal end of the rigid needle shield. In an exemplaryembodiment, the inwardly-projecting first and second inclined or radialwalls 520 a, 520 b, 522 a, 522 b cause the inner diameter of the needleshield remover 500 at the inwardly-projecting shield engagementmechanisms 516 a, 516 b to be less than the outer diameter of thesyringe body. The inner diameter of the needle shield remover 500 at theinwardly-projecting shield engagement mechanisms 516 a, 516 b may besubstantially equal to the outer diameter of the gap formed between thesyringe body and the proximal end of the rigid needle shield. Thisconfiguration of the inwardly-projecting shield engagement mechanisms516 a, 516 b thereby allows the second inclined or radial walls 522 a,522 b to snap into place at the gap in a reliable and tight manner sothat disengagement requires at least a minimal threshold level of force.This configuration also prevents creep of the second inclined or radialwalls 522 a, 522 b out of the gap after assembly but before removal by auser.

The inwardly-projecting shield engagement mechanisms 516 a, 516 b maysnap into place at the gap formed between the rigid needle shield andthe syringe body, as the needle shield remover 500 is inserted over therigid needle shield. When the inwardly-projecting shield engagementmechanisms 516 a, 516 b snap into place at the gap, there may be adecrease in the force experienced against insertion of the needle shieldremover 500 over the rigid needle shield. In an exemplary embodiment,this decrease in the force may be sensed by a user or automatically byan assembly machine to determine that the inwardly-projecting shieldengagement mechanisms 516 a, 516 b have been successfully engaged to thegap formed between the rigid needle shield and the syringe body. In anexemplary embodiment, the positioning of the inwardly-projecting shieldengagement mechanisms 516 a, 516 b in the gap may emit an audible“click” sound that provides an audible indication that the needle shieldremover 500 has been successfully engaged with the rigid needle shield.

In the exemplary embodiment illustrated in FIGS. 5A and 5B, the needleshield remover 500 may be provided as a separate component from a needleshield of the automatic injection device. In another exemplaryembodiment, a needle shield remover may be provided integrally with therigid needle shield, for example, by integrally coupling theinwardly-projecting shield engagement mechanisms 516 a, 516 b of theneedle shield remover 500 with the rigid needle shield.

At or near its proximal edge, the side wall of the proximal tubularmember 502 may also define one or more cutout portions 526 a, 526 b forallowing a user to view of the contents of the syringe and/or to view anindicator from outside the device housing. That is, the cutout portions526 a, 526 b of the proximal tubular member 502 align with a transparentinspection window or inspection aperture of the device housing to allowa user to view the syringe contents and/or to view an indicator fromoutside the device. In the exemplary embodiment of FIGS. 5A and 5B, afirst cutout portion 526 a and a second cutout portion 526 b areprovided at opposite sides of the needle shield remover 500, i.e.,separated from each other by about 180 degrees. In an exemplaryembodiment, the cutout portions 526 a, 526 b may be provided in analternating manner with the inwardly-projecting shield engagementmechanisms 516 a, 516 b, all of which are provided at or near theproximal edge of the proximal tubular member 502. In an exemplaryembodiment, each cutout portion 526 a, 526 b may take a substantiallyconcave shape or a semicircular shape, but is not limited to theseexemplary shapes.

In an exemplary embodiment, one or more additional protrusions and/orgrooves may be provided in the exterior surface of the proximal tubularmember 502 and/or the distal tubular member 504 in order to facilitateengagement of the needle shield remover 500 with another component ofthe automatic injection device, e.g., a syringe sleeve thatcooperatively engages with and covers a proximal portion of the needleshield remover, a removable cap that covers a distal portion of theneedle shield remover, and the like. For example, one or morelongitudinally-extending grooves 528 a, 528 b may be provided in theexterior surface of the needle shield remover 500 to movably engage witha syringe sleeve. In an exemplary embodiment, the syringe sleeve mayallow relative movement of the syringe sleeve and/or the needle shieldremover along the longitudinal axis L, but may hold the needle shieldremover in a substantially fixed axial orientation relative to thesyringe sleeve. This ensures that the cutout portions 526 a, 526 b ofthe needle shield remover 500 are maintained in alignment with atransparent inspection window or inspection aperture of the syringesleeve and with a transparent inspection window or inspection apertureof the device housing, thus allowing a user to view the contents of thesyringe and/or to view an indicator through the inspection windows orinspection apertures.

FIG. 6 illustrates a cross-sectional perspective view of the exemplaryneedle shield remover 500 of FIGS. 5A and 5B assembled with a syringe600 and a distal cap 800. In the exemplary embodiment of FIG. 6, theassembly lacks a syringe sleeve. FIG. 7 illustrates a cross-sectionalperspective view of the exemplary needle shield remover 500 of FIGS. 5Aand 5B assembled with a syringe 600 and a distal cap 800. In theexemplary embodiment of FIG. 7, the assembly includes a syringe sleeve700. FIG. 8 illustrates a front cross-sectional view of the exemplaryassembly of FIG. 7 including a syringe sleeve 700. FIG. 9 illustrates abottom view of an exemplary distal cap 800 that is applicable to FIGS.6-8.

An injection needle 604 may be affixed to a distal end of the syringe600, a bung 606 may be disposed within the syringe 600, and a dose of atherapeutic agent 608 may be provided to fill the syringe 600. Theinjection needle 604 may be covered with a soft needle shield 610 and arigid needle shield 612 disposed over the soft needle shield 610. Theexemplary needle shield remover 500 may be disposed over the rigidneedle shield 612 so that the inwardly-projecting shield engagementmechanisms 516 a, 516 b of the needle shield remover 500 fit within agap between the rigid needle shield 612 and the body of the syringe 600.The cap engagement mechanisms 510 a, 510 b of the needle shield remover500 may engage with a distal cap 800 provided to cover the distalportion of the device. In an exemplary embodiment, the cap engagementmechanisms 510 a, 510 b may be accommodated within a central aperture802 provided in the distal cap 800, so that one or moreinwardly-projecting stop portions 804 a, 804 b (e.g., flanges or raisededges) provided in the central apertures 802 of the distal cap 800 arepositioned reliably within gaps 512 a, 512 b proximal to the capengagement mechanisms 510 a, 510 b. In an exemplary embodiment, a singlestop portion may extend radially around the periphery of the centralaperture 802.

In the exemplary embodiment illustrated in FIGS. 7 and 8, a syringesleeve 700 may be provided over the syringe 600 and the needle shieldremover 500 to maintain the needle shield remover 500 in a substantiallyfixed axial orientation with the device housing.

Exemplary components illustrated in FIGS. 6-9 that are common to thecomponents illustrated in FIGS. 2-3 are described in connection withFIGS. 2-3.

V. SECOND NON-LIMITING EXEMPLARY EMBODIMENT OF A NEEDLE SHIELD REMOVER

FIGS. 10A and 10B illustrate an exemplary needle shield remover 1000having two exemplary inwardly-projecting shield engagement mechanismsfor engagement with a rigid needle shield. FIG. 10A illustrates aperspective view of the exemplary needle shield remover 1000. FIG. 10Billustrates a cross-sectional perspective view of the exemplary needleshield remover 1000 bisected along a longitudinal axis L.

The exemplary needle shield remover 1000 may include a proximal tubularmember 1002 that, at its distal edge, is integrally coupled to a distaltubular member 1004 in some exemplary embodiments. The distal tubularmember 1004 may have a smaller diameter and a shorter length than theproximal tubular member 1002, and may extend along a shorter length ofthe needle shield remover 1000 along the longitudinal axis L than theproximal tubular member 1002. A transition portion 1006 may extendbetween the proximal tubular member 1002 and the distal tubular member1004. An exemplary transition portion 1006 may be a stepped transition,a ramped transition, or a combination of both.

The distal tubular member 1004 of the needle shield remover 1000 may besubstantially cylindrical in shape with a substantially circular or ovalcross-section. At its distal end, the side wall of the distal tubularmember 1004 may include one or more platform structures that projectlongitudinally from the face of the distal tubular member 1004 toward aremovable distal cap. In an exemplary embodiment, a platform structuremay include a first longitudinally-projecting portion 1008 a, a secondlongitudinally-projecting portion 1008 b, and a transverse portion 1008c that extends between the first and second longitudinally-projectingportions 1008 a, 1008 b at the distal end of the platform structure. Thetransverse portion 1008 c may support one or more cap engagementmechanisms in one exemplary embodiment.

At its distal end, an exemplary platform structure may support or defineor provide a first outwardly-projecting flexible cap engagementmechanism 1010 a and a second outwardly-projecting flexible capengagement mechanism 1010 b that project radially outwardly from theplatform structure. Exemplary cap engagement mechanisms may be anysuitable protrusion, projection, teeth, and the like. In the exemplaryembodiment of FIGS. 10A and 10B, the cap engagement mechanisms 1010 a,1010 b are provided at opposite sides of the platform structure, i.e.,separated from each other by about 180 degrees. One of ordinary skill inthe art will recognize that exemplary needle shield removers may includeany suitable number of cap engagement mechanisms extending from theplatform structure including, but not limited to, one, two, three, four,five, six, seven, and the like.

A first end of each cap engagement mechanisms 1010 a, 1010 b may becoupled to or may be provided integrally with the platform structure,and a second end of each cap engagement mechanism 1010 a, 1010 b may besuspended over a gap 1012 a, 1012 b between the cap engagementmechanisms 1010 a, 1010 b and the distal tubular member 1004. Duringassembly of the needle shield remover 1000 with a distal cap of theautomatic injection device (not pictured) provided to cover the needleshield remover, the cap engagement mechanisms 1010 a, 1010 b may becoupled to the distal cap so that removal of the cap also automaticallyremoves the needle shield remover 1000.

In an exemplary embodiment, the cap engagement mechanisms 1010 a, 1010 bof the needle shield remover 1000 may be inserted to fit within acentral aperture provided in the distal cap such that one or moreinwardly-projecting stop portions (e.g., flanges or raised edges)provided in the central aperture of the distal cap reliably engage thegap 1012 a, 1012 b of the needle shield remover 1000. This engagementallows the needle shield remover 1000 to be reliably engaged to thedistal cap after assembly and during removal of the distal cap from thedevice housing, thus causing removal of the distal cap from the devicehousing to automatically remove the needle shield remover 1000 as well.Since the needle shield remover 1000 is reliably engaged to one or moreneedle shields, removal of the needle shield remover, in turn,automatically removes the needle shields coupled to the syringe.

In the exemplary embodiment illustrated in FIGS. 10A and 10B, the needleshield remover 1000 may be provided as a separate component from adistal cap of the automatic injection device. In another exemplaryembodiment, a needle shield remover may be provided integrally with thedistal cap, for example, by integrally coupling the cap engagementmechanisms 1010 a, 1010 b of the needle shield remover 1000 with thedistal cap of the device.

The proximal tubular member 1002 of the needle shield remover 1000 maybe substantially cylindrical in shape with a substantially circular oroval cross-section. The side wall of the proximal tubular member 1002may enclose and define a substantially cylindrical cavity 1014 forhousing the injection needle covered by a soft needle shield and/or arigid needle shield coupled to the syringe.

At or near its proximal edge, the side wall of the proximal tubularmember 1002 may define and/or include a first inwardly-projecting shieldengagement mechanism 1016 a and a second inwardly-projecting shieldengagement mechanism 1016 b. The first and second inwardly-projectingshield engagement mechanisms 1016 a, 1016 b may be biased by the sidewall to reliably remain positioned within a gap formed between the bodyof a syringe and the proximal edge of a rigid needle shield. Exemplaryinwardly-projecting shield engagement mechanisms 1016 a, 1016 b may beany suitable protrusion, projection, teeth, and the like. In theexemplary embodiment of FIGS. 10A and 10B, the exemplaryinwardly-projecting shield engagement mechanisms 1016 a, 1016 b areprovided at opposite sides of the needle shield remover 1000, i.e.,separated from each other by about 180 degrees. The inwardly-projectingshield engagement mechanisms 1016 a, 1016 b may be positioned in a gapformed between a syringe body and a rigid needle shield during theassembly process, and may reliably be positioned in the gap during theuse of the device. When the distal cap covering the injection needle isremoved before performing an injection (by pulling in the directionindicated by arrow R), the inwardly-projecting shield engagementmechanisms 1016 a, 1016 b exert force in the direction R against theperipheral edge of the rigid needle shield, thereby pulling the rigidneedle shield and the soft needle shield away from the syringe body inthe direction R and exposing the injection needle for performing aninjection.

In an exemplary configuration, each inwardly-projecting shieldengagement mechanisms 1016 a, 1016 b may be situated at an aperture 1018a, 1018 b that provides an opening in the side wall of the proximaltubular member 1002. Each inwardly-projecting shield engagementmechanisms 1016 a, 1016 b may include an inwardly-projecting inclined orradial wall 1020 a, 1020 b that extends from a proximal base wall of theaperture 1018 a, 1018 b and projects inwardly into the cavity 1014 at anangle relative to the longitudinal axis L. An exemplary angle may rangefrom about 30 degrees to about 60 degrees relative to the longitudinalaxis L toward the cavity. Providing the shield engagement mechanisms1016 a, 1016 b as part of the proximal tubular member 1002 facilitatesrobust assembly of the needle shield remover 1000 in the automaticinjection device. Projection of the inclined or radial walls of theshield engagement mechanisms 1016 a, 1016 b from the proximal base wallof the aperture 1018 a, 1018 b inwardly into the cavity 1014 alsofacilitates robust assembly of the needle shield remover 1000 in thedevice. These structural features, for example, allow the inclined orradial walls of the needle shield remover 1000 to move radiallyoutwardly with respect to the proximal tubular member 1002, whileminimizing a radially outward movement of the proximal tubular member1002 at the shield engagement mechanisms 1016 a, 1016 b, as the needleshield remover 1000 is inserted coaxially over a needle shield duringassembly. That is, expansion of the outer diameter of the needle shieldremover 1000 is minimized during assembly in order to minimize the riskof the shield engagement mechanisms 1016 a, 1016 b not being positionedat the gap between the needle shield and the syringe body and tominimize the risk of the shield engagement mechanisms 1016 a, 1016 bfrom becoming disengaged from the gap between the needle shield and thesyringe body.

Certain conventional needle shield removers include shield engagementmechanisms that are not formed as a part of a tubular member. Inaddition, in certain conventional needle shield removers, the shieldengagement mechanisms do not extend from a proximal base edge of anaperture or support mechanism. These conventional needle shield removersdo not minimize a radially outward movement needle shield removers atthe shield engagement mechanisms. This radially outward movement of theconventional needle shield removers reduces the robustness of theassembly process as it increases the risk of positioning the shieldengagement mechanisms outside a gap formed between the syringe body andthe needle shield.

In an exemplary embodiment, the proximal tubular member 1002 may bedissected by one or more slots 1001 a, 1001 b that extend substantiallyparallel to the longitudinal axis L at radial locations between theshield engagement mechanisms 1016 a, 1016 b. In an exemplary embodiment,two exemplary slots 1001 a, 1001 b may be separated from each other onthe proximal tubular member 1002 by about 180 degrees. In an exemplaryembodiment, the slots 1001 a, 1001 b may facilitate in engaging theshield engagement mechanisms 1016 a, 1016 b of the needle shield remover1000 with a rigid needle shield.

In this exemplary embodiment, the slots 1001 a, 1001 b may allow theshield engagement mechanisms 1016 a, 1016 b to move radially outwardlyas the needle shield remover 1000 is inserted coaxially over a needleshield during assembly, which advantageously allows the needle shieldremover 1000 to be engaged to the needle shield without requiring theapplication of a large amount of force opposite to the directionindicated by arrow R. Application to a large amount force duringassembly can result in damage to the needle shields and the syringe,thereby adversely affecting the reliability of the assembled needleshield remover.

Exemplary inclined or radial walls may have any suitable dimension andstructure. Exemplary lengths and widths of the inclined or radial wallsmay include, but are not limited to, about 1, 2, 2.1, 2.2, 2.3, 2.4,2.5, 2.6, 2.7, 2.8, 2.9, 3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9,4, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5, 5.1, 5.2, 5.3, 5.4,5.5, 5.6, 5.7, 5.8, 5.9, 6, 6.5, 7 mm, all intermediate numbers, and thelike.

The inclined or radial walls 1020 a, 1020 b of the inwardly-projectingshield engagement mechanisms 1016 a, 1016 b may be configured to bepositioned within a gap formed between a syringe body and a proximaledge of a rigid needle shield. The inclined or radial wall 1020 a, 1020b may have a peripheral edge 1024 a, 1024 b with a width that provides asufficiently large interface with the rigid needle shield. In exemplaryembodiments, the width of the peripheral edge 1024 a, 1024 b may rangefrom about 3 mm to about 7 mm, but is not limited to this exemplaryrange. In an exemplary embodiment, the width is about 5.3 mm.

In an exemplary embodiment, the inwardly-projecting inclined or radialwalls 1020 a, 1020 b cause the inner diameter of the needle shieldremover 1000 at the inwardly-projecting shield engagement mechanisms1016 a, 1016 b to be less than the outer diameter of the proximal end ofthe rigid needle shield. In an exemplary embodiment, theinwardly-projecting inclined or radial walls 1020 a, 1020 b cause theinner diameter of the needle shield remover 1000 at theinwardly-projecting shield engagement mechanisms 1016 a, 1016 b to beless than the outer diameter of the syringe body. The inner diameter ofthe needle shield remover 1000 at the inwardly-projecting shieldengagement mechanisms 1016 a, 1016 b may be substantially equal to theouter diameter of the gap formed between the syringe body and theproximal end of the rigid needle shield. This configuration of theinwardly-projecting shield engagement mechanisms 1016 a, 1016 b therebyallows the inclined or radial walls 1020 a, 1020 b to snap into place atthe gap in a reliable and tight manner so that disengagement requires atleast a minimal threshold level of force. This configuration alsoprevents creep of the inclined or radial walls 1020 a, 1020 b out of thegap after assembly but before removal by a user.

The inwardly-projecting shield engagement mechanisms 1016 a, 1016 b maysnap into place at the gap formed between the rigid needle shield andthe syringe body, as the needle shield remover 1000 is inserted over therigid needle shield. When the inwardly-projecting shield engagementmechanisms 1016 a, 1016 b snap into place at the gap, there may be adecrease in the force experienced against insertion of the needle shieldremover 1000 over the rigid needle shield. In an exemplary embodiment,this decrease in the force may be sensed by a user or automatically byan assembly machine to determine that the inwardly-projecting shieldengagement mechanisms 1016 a, 1016 b have been successfully engaged tothe gap formed between the rigid needle shield and the syringe body. Inan exemplary embodiment, the positioning of the inwardly-projectingshield engagement mechanisms 1016 a, 1016 b in the gap may emit anaudible “click” sound that provides an audible indication that theneedle shield remover 1000 has been successfully engaged with the rigidneedle shield.

In the exemplary embodiment illustrated in FIGS. 10A and 10B, the needleshield remover 1000 may be provided as a separate component from aneedle shield of the automatic injection device. In another exemplaryembodiment, a needle shield remover may be provided integrally with therigid needle shield, for example, by integrally coupling theinwardly-projecting shield engagement mechanisms 1016 a, 1016 b of theneedle shield remover 1000 with the rigid needle shield.

At or near its proximal edge, the side wall of the proximal tubularmember 1002 may also define one or more cutout portions 1026 a, 1026 bfor allowing a user to view of the contents of the syringe and/or toview an indicator from outside the device housing. That is, the cutoutportions 1026 a, 1026 b of the proximal tubular member 1002 align with atransparent inspection window or inspection aperture of the devicehousing to allow a user to view the syringe contents and/or to view anindicator from outside the device. In the exemplary embodiment of FIGS.10A and 10B, a first cutout portion 1026 a and a second cutout portion1026 b are provided at opposite sides of the needle shield remover 1000,i.e., separated from each other by about 180 degrees. In an exemplaryembodiment, the cutout portions 1026 a, 1026 b may be provided in analternating manner with the inwardly-projecting shield engagementmechanisms 1016 a, 1016 b, all of which are provided at or near theproximal edge of the proximal tubular member 1002. In an exemplaryembodiment, each cutout portion 1026 a, 1026 b may take a substantiallyconcave shape or a semicircular shape, but is not limited to theseexemplary shapes. In an exemplary embodiment, the distal ends of thecutout portions 1026 a, 1026 b may contiguously join with the dissectionslots 1001 a, 1001 b.

In an exemplary embodiment, one or more additional protrusions and/orgrooves may be provided in the exterior surface of the proximal tubularmember 1002 and/or the distal tubular member 1004 in order to facilitateengagement of the needle shield remover 1000 with another component ofthe automatic injection device, e.g., a syringe sleeve thatcooperatively engages with and covers a proximal portion of the needleshield remover, a removable cap that covers a distal portion of theneedle shield remover, and the like. For example, one or morelongitudinally-extending grooves 1028 a, 1028 b may be provided in theexterior surface of the needle shield remover 1000 to movably engagewith a syringe sleeve. In an exemplary embodiment, the syringe sleevemay allow relative movement of the syringe sleeve and/or the needleshield remover along the longitudinal axis L, but may hold the needleshield remover in a substantially fixed axial orientation relative tothe syringe sleeve. This ensures that the cutout portions 1026 a, 1026 bof the needle shield remover 1000 are maintained in alignment with atransparent inspection window or inspection aperture of the syringesleeve and with a transparent inspection window or inspection apertureof the device housing, thus allowing a user to view the contents of thesyringe and/or to view an indicator through the inspection windows orinspection apertures.

FIG. 11 illustrates a perspective cross-sectional view of the exemplaryneedle shield remover 1000 of FIGS. 10A and 10B assembled with a syringe600 and a distal cap 800. In the exemplary embodiment of FIG. 11, theassembly lacks a syringe sleeve. FIG. 12 illustrates a perspectivecross-sectional view of the exemplary needle shield remover 1000 ofFIGS. 10A and 10B assembled with a syringe 600 and a distal cap 800. Inthe exemplary embodiment of FIG. 12, the assembly includes a syringesleeve 700. FIG. 13 illustrates a front cross-sectional view of theexemplary assembly of FIG. 12 including a syringe sleeve 700. FIG. 14illustrates a bottom view of an exemplary distal cap 800 that isapplicable to FIGS. 11-13.

An injection needle 604 may be affixed to a distal end of the syringe600, a bung 606 may be disposed within the syringe 600, and a dose of atherapeutic agent 608 may be provided to fill the syringe 600. Theinjection needle 604 may be covered with a soft needle shield 610 and arigid needle shield 612 disposed over the soft needle shield 610. Theexemplary needle shield remover 1000 may be disposed over the rigidneedle shield 612 so that the inwardly-projecting shield engagementmechanisms 1016 a, 1016 b of the needle shield remover 1000 fit within agap between the rigid needle shield 612 and the body of the syringe 600.The cap engagement mechanisms 1010 a, 1010 b of the needle shieldremover 1000 may engage with a distal cap 800 provided to cover thedistal portion of the device. In an exemplary embodiment, the capengagement mechanisms 1010 a, 1010 b may be accommodated within acentral aperture 802 provided in the distal cap 800, so thatinwardly-projecting stop portions 804 a, 804 b (e.g., flanges or raisededges) provided in the central aperture of the distal cap are positionedreliably within gaps 1012 a, 1012 b proximal to the cap engagementmechanisms 1010 a, 1010 b.

In the exemplary embodiment illustrated in FIGS. 12 and 13, a syringesleeve 700 may be provided over the syringe 600 and the needle shieldremover 1000 to maintain the needle shield remover 1000 in asubstantially fixed axial orientation with the device housing.

Exemplary components illustrated in FIGS. 11-14 that are common to thecomponents illustrated in FIGS. 2-3 are described in connection withFIGS. 2-3.

VI. THIRD NON-LIMITING EXEMPLARY EMBODIMENT OF A NEEDLE SHIELD REMOVER

FIGS. 15A and 15B illustrate an exemplary needle shield remover 1500having three exemplary inwardly-projecting shield engagement mechanismsfor engagement with a rigid needle shield. FIG. 15A illustrates aperspective view of the exemplary needle shield remover 1500. FIG. 15Billustrates a cross-sectional perspective view of the exemplary needleshield remover 1500 bisected along a longitudinal axis L.

The exemplary needle shield remover 1500 may include a proximal tubularmember 1502 that, at its distal edge, is integrally coupled to a distaltubular member 1504 in some exemplary embodiments. The distal tubularmember 1504 may have a smaller diameter and a shorter length than theproximal tubular member 1502, and may extend along a shorter length ofthe needle shield remover 1500 along the longitudinal axis L than theproximal tubular member 1502. A transition portion 1506 may extendbetween the proximal tubular member 1502 and the distal tubular member1504. An exemplary transition portion 1506 may be a stepped transition,a ramped transition, or a combination of both.

The distal tubular member 1504 of the needle shield remover 1500 may besubstantially cylindrical in shape with a substantially circular or ovalcross-section. At its distal end, the side wall of the distal tubularmember 1504 may include one or more platform structures 1508 thatproject longitudinally from the face of the distal tubular member 1504toward a removable distal cap. In an exemplary embodiment, a platformstructure 1508 may include one or more longitudinally-projectingportions and a transverse portion that extends between thelongitudinally-projecting portions at the distal end of the platformstructure 1508.

At its distal end, one or more platform structures 1508 may support ordefine or provide a first outwardly-projecting flexible cap engagementmechanism 1510 a, a second outwardly-projecting flexible cap engagementmechanism 1510 b and a third outwardly-projecting flexible capengagement mechanism 1510 c, that project radially outwardly from theplatform structure 1508. Providing three cap engagement mechanisms inthis exemplary embodiment provides a larger surface of the needle shieldremover that engages with the distal cap than embodiments that includeone or two cap engagement mechanism. The exemplary needle shield remover1500 thereby allows reliably removal of the needle shield remover fromthe syringe when the distal cap is removed before administration of aninjection.

Exemplary cap engagement mechanisms may be any suitable protrusion,projection, teeth, and the like. In the exemplary embodiment of FIGS.15A and 15B, the cap engagement mechanisms 1510 a, 1510 b, 1510 c arespaced from one another around the platform structure 1508, i.e.,separated by about 120 degrees. One of ordinary skill in the art willrecognize that exemplary needle shield removers may include any suitablenumber of cap engagement mechanisms extending from the platformstructure 1508 including, but not limited to, one, two, three, four,five, six, seven, and the like.

A first end of each cap engagement mechanisms 1510 a, 1510 b, 1510 c maybe coupled to or may be provided integrally with the platform structure1508, and a second end of each cap engagement mechanism 1510 a, 1510 b,1510 c may be suspended over a gap (e.g., gap 1512 a, 1512 b, 1512 c)between the cap engagement mechanisms 1510 a, 1510 b, 1510 c and thedistal tubular member 1504. During assembly of the needle shield remover1500 with a distal cap of the automatic injection device (not pictured)provided to cover the needle shield remover, the cap engagementmechanisms 1510 a, 1510 b, 1510 c may be coupled to the distal cap sothat removal of the cap also automatically removes the needle shieldremover 1500.

In an exemplary embodiment, the cap engagement mechanisms 1510 a, 1510b, 1510 c of the needle shield remover 1500 may be inserted to fitwithin a central aperture provided in the distal cap such that one ormore inwardly-projecting stop portions (e.g., flanges or raised edges)provided in the central aperture of the distal cap reliably engage thegaps 1512 a, 1512 b, 1512 c of the needle shield remover 1500. Thisengagement allows the needle shield remover 1500 to be reliably engagedto the distal cap after assembly and during removal of the distal capfrom the device housing, thus causing removal of the distal cap from thedevice housing to automatically remove the needle shield remover 1500 aswell. Since the needle shield remover 1500 is reliably engaged to one ormore needle shields, removal of the needle shield remover, in turn,automatically removes the needle shields.

In the exemplary embodiment illustrated in FIGS. 15A and 15B, the needleshield remover 1500 may be provided as a separate component from adistal cap of the automatic injection device. In another exemplaryembodiment, a needle shield remover may be provided integrally with thedistal cap, for example, by integrally coupling the cap engagementmechanisms 1510 a, 1510 b, 1510 c of the needle shield remover 1500 withthe distal cap of the device.

The proximal tubular member 1502 of the needle shield remover 1500 maybe substantially cylindrical in shape with a substantially circular oroval cross-section. The side wall of the proximal tubular member 1502may enclose and define a substantially cylindrical cavity 1514 forhousing the injection needle covered by a soft needle shield and/or arigid needle shield.

At or near its proximal edge, the side wall of the proximal tubularmember 1502 may define and/or include a first inwardly-projecting shieldengagement mechanism 1516 a, a second inwardly-projecting shieldengagement mechanism 1516 b, and a third inwardly-projecting shieldengagement mechanism 1516 c. The first, second and thirdinwardly-projecting shield engagement mechanisms 1516 a, 1516 b, 1516 cmay be biased by the side wall to reliably remain positioned within agap formed between the body of a syringe and the proximal edge of arigid needle shield. Exemplary inwardly-projecting shield engagementmechanisms 1516 a, 1516 b, 1516 c may be any suitable protrusion,projection, teeth, and the like. In the exemplary embodiment of FIGS.15A and 15B, the exemplary inwardly-projecting shield engagementmechanisms 1516 a, 1516 b, 1516 c may be spaced from one another aroundthe needle shield remover 1500, i.e., separated from each other by about120 degrees.

The inwardly-projecting shield engagement mechanisms 1516 a, 1516 b,1516 c may be positioned in a gap formed between a syringe body and arigid needle shield during the assembly process, and may reliably bepositioned in the gap during the use of the device. When the distal capcovering the injection needle is removed before performing an injection(by pulling in the direction indicated by arrow R), theinwardly-projecting shield engagement mechanisms 1516 a, 1516 b, 1516 cexert force in the direction R against the peripheral edge of the rigidneedle shield, thereby pulling the rigid needle shield and the softneedle shield away from the syringe body in the direction R and exposingthe injection needle for performing an injection.

In an exemplary configuration, each inwardly-projecting shieldengagement mechanism 1516 a, 1516 b, 1516 c may be situated at anaperture 1518 a, 1518 b, 1518 c that provides an opening in the sidewall of the proximal tubular member 1502. Each inwardly-projectingshield engagement mechanisms 1516 a, 1516 b, 1516 c may include a firstinclined or radial wall 1520 a, 1520 b, 1520 c that extends from aproximal wall of the aperture 1518 a, 1518 b, 1518 c into the cavity1514 at a first angle relative to the longitudinal axis L. The firstinclined or radial wall 1520 a, 1520 b, 1520 c may be coupled to or maybe integrally formed with an inwardly-projecting second inclined orradial wall 1522 a, 1522 b, 1522 c. The second inclined or radial wall1522 a, 1522 b, 1522 c may extend from the first inclined or radial wallinto the cavity 1514 at a second angle relative to the longitudinal axisL.

The second angle corresponding to the second inclined or radial wall1522 a, 1522 b, 1522 c may be substantially greater than the first anglecorresponding to the first inclined or radial wall 1520 a, 1520 b, 1520c, so that the first inclined or radial wall 1520 a, 1520 b, 1520 cextends substantially along the longitudinal axis L and the secondinclined or radial wall 1522 a, 1522 b, 1522 c extends substantiallyorthogonally to the longitudinal axis L. An exemplary first angle mayrange from about 0 degree to about 20 degrees relative to thelongitudinal axis L toward the cavity 1514. An exemplary second anglemay range from about 30 degrees to about 60 degrees relative to thelongitudinal axis L toward the cavity 1514.

Providing the shield engagement mechanisms 1516 a, 1516 b, 1516 c aspart of the proximal tubular member 1502 facilitates robust assembly ofthe needle shield remover 1500 in the automatic injection device.Projection of the inclined or radial walls of the shield engagementmechanisms 1516 a, 1516 b, 1516 c from the proximal base wall of theaperture 1518 a, 1518 b, 1518 c inwardly into the cavity 1514 alsofacilitates robust assembly of the needle shield remover 1500 in thedevice. These structural features, for example, allow the inclined orradial walls of the needle shield remover 1500 to move radiallyoutwardly with respect to the proximal tubular member 1502, whileminimizing a radially outward movement of the proximal tubular member1502 at the shield engagement mechanisms 1516 a, 516 b, 1516 c, as theneedle shield remover 1500 is inserted coaxially over a needle shieldduring assembly. That is, expansion of the outer diameter of the needleshield remover 1500 is minimized during assembly in order to minimizethe risk of the shield engagement mechanisms 1516 a, 1516 b, 1516 c notbeing positioned at the gap between the needle shield and the syringebody and to minimize the risk of the shield engagement mechanisms 1516a, 1516 b, 1516 c from becoming disengaged from the gap between theneedle shield and the syringe body.

Certain conventional needle shield removers include shield engagementmechanisms that are not formed as a part of a tubular member. Inaddition, in certain conventional needle shield removers, the shieldengagement mechanisms do not extend from a proximal base edge of anaperture or support mechanism. These conventional needle shield removersdo not minimize a radially outward movement needle shield removers atthe shield engagement mechanisms. This radially outward movement of theconventional needle shield removers reduces the robustness of theassembly process as it increases the risk of positioning the shieldengagement mechanisms outside a gap formed between the syringe body andthe needle shield.

Exemplary first and second inclined or radial walls may have anysuitable dimension and structure. Exemplary lengths and widths of thefirst and second inclined or radial walls may include, but are notlimited to, about 1, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3,3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4, 4.1, 4.2, 4.3, 4.4, 4.5,4.6, 4.7, 4.8, 4.9, 5, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6,6.5, 7 mm, all intermediate numbers, and the like.

The second inclined or radial wall 1522 a, 1522 b, 1522 c of theinwardly-projecting shield engagement mechanisms 1516 a, 1516 b, 1516 cmay be configured to be positioned within a gap formed between a syringebody and a proximal edge of a rigid needle shield. Providing threeinwardly-projecting shield engagement mechanisms 1516 a, 1516 b, 1516 cin this exemplary embodiment provides a larger surface of the needleshield remover that engages with the rigid needle shield thanembodiments that include one or two inwardly-projecting shieldengagement mechanism. The exemplary needle shield remover 1500 therebyallows reliably removal of the needle shields from the syringe when theneedle shield remover is removed before administration of an injection.The second inclined or radial wall 1522 a, 1522 b, 1522 c may have aperipheral edge 1524 a, 1524 b, 1524 c with a width that provides asufficiently large interface with the rigid needle shield. In exemplaryembodiments, the width of the peripheral edge 1524 a, 1524 b, 1524 c mayrange from about 3 mm to about 7 mm, but is not limited to thisexemplary range. In an exemplary embodiment, the width is about 5.4 mm.The greater width of the peripheral edge of the second inclined orradial wall 1522 a, 1522 b, 1522 c also provides a larger surface of theneedle shield remover that engages with the rigid needle shield thanembodiments that include one or two inwardly-projecting shieldengagement mechanism, allowing reliable removal of the needle shieldsfrom the syringe when the needle shield remover is removed beforeadministration of an injection

In an exemplary embodiment, the inwardly-projecting first and secondinclined or radial walls cause the inner diameter of the needle shieldremover 1500 at the inwardly-projecting shield engagement mechanisms1516 a, 1516 b, 1516 c to be less than the outer diameter of theproximal end of the rigid needle shield. In an exemplary embodiment, theinwardly-projecting first and second inclined or radial walls cause theinner diameter of the needle shield remover 1500 at theinwardly-projecting shield engagement mechanisms 1516 a, 1516 b, 1516 cto be less than the outer diameter of the syringe body. The innerdiameter of the needle shield remover 1500 at the inwardly-projectingshield engagement mechanisms 1516 a, 1516 b, 1516 c may be substantiallyequal to the outer diameter of the gap formed between the syringe bodyand the proximal end of the rigid needle shield. This configuration ofthe inwardly-projecting shield engagement mechanisms 1516 a, 1516 b,1516 c thereby allows the second inclined or radial walls 1522 a, 1522b, 1522 c to snap into place at the gap in a reliable and tight mannerso that disengagement requires at least a minimal threshold level offorce. This configuration also prevents creep of the second inclined orradial walls 1522 a, 1522 b, 1522 c out of the gap after assembly butbefore removal by a user.

The inwardly-projecting shield engagement mechanisms 1516 a, 1516 b,1516 c may snap into place at the gap formed between the rigid needleshield and the syringe body, as the needle shield remover 1500 isinserted over the rigid needle shield. When the inwardly-projectingshield engagement mechanisms 1516 a, 1516 b, 1516 c snap into place atthe gap, there may be a decrease in the force experienced againstinsertion of the needle shield remover 1500 over the rigid needleshield. In an exemplary embodiment, this decrease in the force may besensed by a user or automatically by an assembly machine to determinethat the inwardly-projecting shield engagement mechanisms 1516 a, 1516b, 1516 c have been successfully engaged to the gap formed between therigid needle shield and the syringe body. In an exemplary embodiment,the positioning of the inwardly-projecting shield engagement mechanisms1516 a, 1516 b, 1516 c in the gap may emit an audible “click” sound thatprovides an audible indication that the needle shield remover 1500 hasbeen successfully engaged with the rigid needle shield.

In the exemplary embodiment illustrated in FIGS. 15A and 15B, the needleshield remover 1500 may be provided as a separate component from adistal cap of the automatic injection device. In another exemplaryembodiment, a needle shield remover may be provided integrally with thedistal cap, for example, by integrally coupling the inwardly-projectingshield engagement mechanisms 1516 a, 1516 b, 1516 c of the needle shieldremover 1500 with the distal cap of the device.

In an exemplary embodiment, one or more additional protrusions and/orgrooves may be provided in the exterior surface of the proximal tubularmember 1502 and/or the distal tubular member 1504 in order to facilitateengagement of the needle shield remover 1500 with another component ofthe automatic injection device, e.g., a syringe sleeve that cooperativeengages with and covers a proximal portion of the needle shield remover,a removable cap that covers a distal portion of the needle shieldremover, and the like.

FIG. 16 illustrates a perspective cross-sectional view of the exemplaryneedle shield remover 1500 of FIGS. 15A and 15B assembled with a syringe600 and a distal cap 800. In the exemplary embodiment of FIG. 16, theassembly lacks a syringe sleeve. FIG. 17 illustrates a perspectivecross-sectional view of the exemplary needle shield remover 1500 ofFIGS. 15A and 15B assembled with a syringe 600 and a distal cap 800. Inthe exemplary embodiment of FIG. 17, the assembly includes a syringesleeve 700. FIG. 18 illustrates a front cross-sectional view of theexemplary assembly of FIG. 17 including a syringe sleeve 700. FIG. 19illustrates a bottom view of an exemplary distal cap 800 that isapplicable to FIGS. 16-18.

An injection needle 604 may be affixed to a distal end of the syringe600, a bung 606 may be disposed within the syringe 600, and a dose of atherapeutic agent 608 may be provided to fill the syringe 600. Theinjection needle 604 may be covered with a soft needle shield 610 and arigid needle shield 612 disposed over the soft needle shield 610. Theexemplary needle shield remover 1500 may be disposed over the rigidneedle shield 612 so that the inwardly-projecting shield engagementmechanisms 1516 a, 1516 b, 1516 c of the needle shield remover 1500 fitwithin a gap between the rigid needle shield 612 and the body of thesyringe 600. The cap engagement mechanisms 1510 a, 1510 b, 1510 c of theneedle shield remover 1500 may engage with a distal cap 800 provided tocover the distal portion of the device. In an exemplary embodiment, thecap engagement mechanisms 1510 a, 1510 b, 1510 c may be accommodatedwithin a central aperture 802 provided in the distal cap 800, so thatinwardly-projecting stop portions 804 a, 804 b, 804 c (e.g., flanges orraised edges) provided in the central aperture of the distal cap arepositioned reliably within gaps 1512 a, 1512 b, 1512 c proximal to thecap engagement mechanisms 1510 a, 1510 b, 1510 c.

In an exemplary embodiment illustrated in FIGS. 17 and 18, a syringesleeve 700 may be provided over the syringe 600 and the needle shieldremover 1500 to maintain the needle shield remover 1500 in asubstantially fixed axial orientation with the device housing.

Exemplary components illustrated in FIGS. 16-19 that are common to thecomponents illustrated in FIGS. 2-3 are described in connection withFIGS. 2-3.

VII. CERTAIN OTHER NON-LIMITING EXEMPLARY EMBODIMENTS OF NEEDLE SHIELDREMOVERS

FIG. 20 illustrates a cross-sectional view of an exemplary needle shieldremover 2000 bisected along the longitudinal axis L. The needle shieldremover 2000 is configured for removing needle shields from a syringe2002 or an automatic injection device. The syringe 2002 may include anytype of syringe typically utilized with an automatic injection devicehaving one or more needle shields, such as a soft needle shield 2004 anda rigid needle shield 2006. As discussed above, the soft needle shield2004 is positioned within the rigid needle shield 2006, and portions ofthe soft needle shield 2004 extend through apertures 2008 formed in therigid needle shield 2006.

The needle shield remover 2000 includes a outer wall 2010 which isattached to and depends from (or is formed integrally with) theperiphery of an base wall 2012, and one or more inwardly-facingprotrusions or teeth 2014 which are biased by the outer wall 2010 inposition within a gap formed between the body of the syringe 2002 andthe periphery 2016 of the rigid needle shield 2006. The outer wall 2010and base wall 2012 may have any desired shape or size (e.g., the needleshield remover 2000 may be cylindrical or other shape), and a pluralityof outer walls 2010 may be provided (e.g., if the needle shield remover2000 is square or rectangular in shape). The needle shield remover 2000defines a cavity that receives the soft needle shield 2004 and the rigidneedle shield 2006. A plurality of outer protrusions 2018 may beprovided on the outer surface of the outer wall 2010, to facilitatefixed engagement of the needle shield remover 2000 within a removablecap of an automatic injection device to provide a gripping surface tothe removable cap. In this manner the removable cap cooperativelyengages with the gripping surface defined by the plurality ofprotrusions 2018 and the plurality of valleys to reliably remove therigid needle shield 2006 and the soft needle shield 2004 from thesyringe or the automatic injection device.

When the needle shield remover 2000 is pulled away from the syringe body2002 (as shown by arrow R), the protrusions 2014 exert force against theperiphery 2016 of the rigid needle shield 2006, thereby pulling therigid needle shield 2006 and the soft needle shield 2004 away from thesyringe body 2002 and exposing the needle of the syringe 2002 for use.It is noted that the protrusions 2014 may also be configured to fitwithin the apertures 2008 of the rigid needle shield 2006, or tootherwise contact the rigid needle shield 2006 (e.g., to fit withincorresponding recesses formed in the rigid needle shield 2006).

FIG. 21 illustrates a cross-sectional view of another exemplary needleshield remover 2100 bisected along the longitudinal axis L. In thisembodiment, the needle shield remover 2100 includes an inner (first)wall 2102 which is positioned coaxially within an outer (second) wall2104, and which is coupled to the outer wall 2104 by a hollow projection2106 extending through an aperture formed in a base wall 2108 that isjoined at its periphery to the outer wall 2104 (or formed integrallytherewith). Similar to the embodiment shown and discussed above inconnection with FIG. 20, the inner wall 2102 includes one or moreprotrusions 2110 extending therefrom which are biased in a gap formedbetween the syringe body 2112 and the lower periphery 2114 of the rigidneedle shield 2116. The inner wall 2102 may be fixedly or rotatablycoupled to the outer wall 2104. One or more protrusions 2118, forexample a flange or collar, may be formed at a base end of the hollowprojection 2106, so as to couple the base wall 2108 and the outer wall2104. The inner wall 2102 and the outer wall 2104 may have a circularcross section, an elongated cross section, square cross section,rectangular cross section or any other suitable cross section. The outerwall 2104 may be fixedly coupled to inner surfaces of a removable cap ofan automatic injection device, and, as shown in FIG. 21, may include oneor more protrusions 2120 to facilitate such coupling and to provide agripping surface for the removable cap. The protrusions may be rings,collars, flanges or other type of protrusion.

When the outer wall 2104 is pulled away from the syringe body 2112 (asindicated by arrow R), it pulls the inner wall 2102 away from thesyringe body 2112, thereby causing the protrusions 2110 to exert forceagainst the lower periphery 2114 of the rigid needle shield 2116 and topull the rigid needle shield 2116 and the soft needle shield 2122 awayfrom the syringe 2112 to expose the needle for use. As with priorembodiments, it is noted that the protrusions 2110 may be positioned atother locations, e.g., they may be positioned to extend into theapertures 2124 in the rigid needle shield 2116 or to contact otherlocations (e.g., corresponding recesses) on the rigid needle shield2116.

FIG. 22 illustrates a cross-sectional view of an exemplary needle shieldremover 2200 bisected along the longitudinal axis L. The needle shieldremover 2200 includes an outer wall 2202 that depends from and isconnected to the periphery of a base wall 2204 (or, formed integrallytherewith). As mentioned in connection with earlier embodiments, theneedle shield remover 2200 may have any shape (e.g., cylindrical orother shape). An annular recess 2206 with an annular opening or aplurality of apertures radially spaced circumferentially about theannular recess is provided along one end of the outer wall 2202, andreceives removal element 2208, for example, an annular washer, ring orpins having one or more protrusions 2218 extending through correspondingapertures formed in the recess 2206. Ends of the protrusions 2218 arepositioned in a gap formed between the syringe body 2212 and the lowerperiphery 2214 of the rigid needle shield 2216. The needle shieldremover 2200 may be fixedly coupled to inner surfaces of a removable capof an automatic injection device.

When the needle shield remover 2200 is pulled away from the syringe 2212(as indicated by arrow R), the protrusions 2218 exert force against thelower periphery 2214 of the rigid needle shield 2216 and pull the rigidneedle shield 2216 and the soft needle shield 2220 away from the syringe2212, thereby exposing the needle for use. It is noted that the removalelement 2208 may be positioned so that the protrusions contact otherlocations, e.g., they may be positioned to extend into the apertures2222 of the rigid needle shield 2216 or contact other locations of therigid needle shield 2216 (e.g., they may contact corresponding recessesformed in the rigid needle shield 2216).

FIG. 23 illustrates a cross-sectional view of an exemplary needle shieldremover 2300 bisected along the longitudinal axis L. The needle shieldremover 2300 includes a modified rigid needle shield 2302 having a topaperture 2304, and a captive component 2306 which is coupled to therigid needle shield 2302. The captive component 2306 includes a hollowaxle 2308 that extends through the aperture 2304. Shoulders 2310 of therigid needle shield 2302 are captured between a peripheral wall 2312 ofthe captive component 2306 and a transverse annular wall 2314 formed ata lower end of the axle 2308 and positioned between the shoulders 2310and the soft needle shield 2316. Portions of the soft needle shield 2316extend through apertures 2318 formed in the rigid needle shield 2302.Protrusions 2320 are provided at a base end of the axle 2308 forcoupling (e.g., by way of snap fit) the captive component 2306 to aremovable cap of an automatic injection device. When the captivecomponent 2306 is pulled away from a syringe (as indicated by arrow R),the transverse annular wall 2314 exerts force against the shoulders2310, thereby pulling the rigid needle shield 2302 and the soft needleshield 2316 away from a syringe and exposing the needle for use.

FIG. 24 illustrates a cross-sectional view of an exemplary needle shieldremover 2400 bisected along the longitudinal axis L. The needle shieldremover 2400 includes an outer wall 2402 extending from and connected to(or formed integrally with) a base wall 2404, and an inner wall 2406extending from and connected to (or formed integrally with) the basewall 2404. The outer wall 2402 and the inner wall 2406 may be annularlyaligned about a central longitudinal axis of the syringe. The outer wall2402 and the inner wall 2406 may have a circular cross section, anelongated cross section, square cross section, rectangular cross sectionor any other suitable cross section.

A collar or spring clip 2408 extends through apertures formed in one end2410 of the inner wall 2406, and contact the soft needle shield 2412through the apertures 2414 of the rigid needle shield 2416. One or moreprotrusions 2418 are formed at the lower end 2410 of the inner wall 2406and are positioned in a gap formed between the syringe body 2420 and thelower periphery 2422 of the rigid needle shield 2416. The collar/springclip 2408 stabilizes the protrusions 2418 to prevent them from creepingout of the gap between the syringe body 2420 and the lower periphery2422 of the rigid needle shield 2416. It is noted that the outer wall2402 may be fixedly coupled to inner surfaces of a removable cap of anautomatic injection device, and, as shown in FIG. 24, may include one ormore protrusions 2424 to facilitate such coupling and to provide agripping surface for the removable cap. The protrusions may be rings,collars, flanges or other type of protrusion.

When the needle shield remover 2400 is pulled away from the syringe 2420(as indicated by arrow R), the collar 2408 and the protrusions 2418exert force against the rigid needle shield 2416, thereby pulling therigid needle shield 2416 and the soft needle shield 2412 away from thesyringe 2420 and exposing the needle for use. It is noted that thecollar/spring clip 2408, and/or the protrusions 2418, may be positionedto contact other locations of the rigid needle shield 2416 and/or thesoft needle shield 2412. The needle shield remover 2400 may be fixedlycoupled to inner surfaces of a removable cap of an automatic injectiondevice.

It is noted that, in each of the embodiments discussed herein, thevarious protrusions which contact the rigid needle shield to remove itfrom the syringe may be permanently attached to the rigid needle shield,e.g., by way of gluing/epoxy. Of course, such a feature is entirelyoptional, and the protrusions need not be permanently attached to therigid needle shield.

VIII. EXEMPLARY METHODS OF ASSEMBLING AND USING AUTOMATIC INJECTIONDEVICES

Exemplary needle shield removers are configured and designed for quick,easy and reliable engagement to both a distal cap of an automaticinjection device and to one or more needle shields covering an injectionneedle of the device. One or more exemplary methods may be used toassemble an exemplary needle shield remover with the other components ofthe device.

In an exemplary method, an exemplary needle shield remover may beassembled with a syringe after the syringe has been inserted into thehousing of the device.

In another exemplary method, an exemplary needle shield remover—that isprovided as a separate component from a distal cap and from a needleshield—may be assembled with a syringe prior to insertion of the syringeinto the housing of the device. The ability to assemble the exemplaryneedle shield remover with the syringe outside the device housing allowsvisual inspection of the assembly process to ensure that the needleshield remover is correctly and reliably engaged with the needle shieldon the syringe before the syringe and needle shield remover assembly isinserted into the device housing. Thus, assembly of the exemplary needleshield remover in the automatic injection device allows one to becertain that, when the syringe assembly is inserted into the devicehousing, the needle shield remover is engaged reliably and consistentlywith the needle shield. This resolves the issue of component toleranceand unreliable positioning of needle shield removal mechanisms inconventional automatic injection devices.

FIG. 25 is a flowchart of an exemplary method 2500 for assembling anexemplary needle shield remover with a syringe and a distal cap of anautomatic injection device, in which the needle shield remover isassembled with the syringe prior to insertion of the syringe into thehousing of an automatic injection device.

In step 2502, a suitable injection needle may be coupled to a distal endof the syringe. In step 2504, a bung may be disposed within the syringeto seal the contents of the syringe. In step 2506, the syringe may befilled with a dose of a therapeutic agent. In step 2508, the injectionneedle may be covered by one or more soft needle shields and/or one ormore rigid needle shields.

In step 2510, a needle shield remover may be engaged to the rigid needleshield attached to the syringe prior to insertion of the syringe intothe housing of the device. The ability to assemble the exemplary needleshield remover to the syringe outside the device housing allows visualinspection of the assembly process to ensure that the needle shieldremover reliably engages the needle shield on the syringe before thesyringe assembly is inserted into the device housing.

In an exemplary embodiment, one or more inwardly-projecting shieldengagement mechanisms of the needle shield remover may be engaged to agap formed between the proximal end of the rigid needle shield and thesyringe body. In an exemplary embodiment, as the needle shield removeris positioned surrounding the rigid needle shield, the shield engagementmechanisms may snap into place at the gap and may not be disengagedduring the assembly process. When the inwardly-projecting shieldengagement mechanisms snap into place at the gap, there may be adecrease in the force experienced against insertion of the needle shieldremover over the rigid needle shield. In an exemplary embodiment, thisdecrease in the force may be sensed by a user or automatically by anassembly machine to determine that the inwardly-projecting shieldengagement mechanisms have been successfully engaged to the needleshield at the gap. In an exemplary embodiment, positioning of the shieldengagement components at the gap may emit an audible “click” sound thatprovides an audible indication that the needle shield remover has beensuccessfully engaged with the rigid needle shield.

In another exemplary embodiment, one or more inwardly-projecting shieldengagement mechanisms of the needle shield remover may be engaged to oneor more apertures defined in a rigid needle shield. In another exemplaryembodiment, one or more inwardly-projecting shield engagement mechanismsof the needle shield remover may be engaged to one or more ridgedportions in the exterior surface of the rigid needle shield.

In step 2512, in an exemplary embodiment, a syringe sleeve may beengaged with the syringe and needle shield remover. The syringe sleevemay be maintained in a substantially fixed axial orientation relative tothe device housing. The syringe sleeve may, in turn, maintain the needleshield remover in a substantially fixed axial orientation relative tothe syringe sleeve. This assembly aligns the cutout portions of theneedle shield remover with the inspection window or inspection apertureof the syringe sleeve and with the inspection window or inspectionaperture of the device housing. This allows a user to view the contentsof the syringe and/or an end-of-injection indicator through theinspection window or inspection aperture of the device housing.

In another exemplary embodiment, a syringe sleeve may be absent in theautomatic injection device and step 2512 may be skipped. In thisexemplary embodiment, the axial orientation of the needle shield removermay be manually or automatically adjusted relative to the device housingso that the cutout portions of the needle shield remover are alignedwith the inspection window or inspection aperture of the device housing.This allows a user to view the contents of the syringe and/or to view anindicator through the inspection window or inspection aperture of thedevice housing.

In step 2514, the syringe, needle shield remover and syringe sleeveassembly may be inserted into the device housing through a proximal endof the device housing.

In step 2516, a proximal cap may be coupled to the proximal end of thedevice housing to seal the proximal end.

In step 2518, a distal cap may be coupled to the distal end of thedevice housing so that the distal cap is engaged to both the distal endof the housing and to the needle shield remover in one step. In anexemplary embodiment, as the distal cap is inserted over the needleshield remover disposed at the distal end of the device housing, one ormore cap engagement mechanisms of the needle shield remover may fitwithin a central aperture provided in the distal cap. One or moreinwardly-projecting stop portions (e.g., flanges or raised edges)provided in the central aperture of the distal cap may snap into placewithin a gap formed under the cap engagement mechanisms. When the capengagement mechanisms snap into place at the gap over theinwardly-projecting stop portions in the central aperture of the distalcap, there may be a decrease in the force experienced against insertionof the distal cap over the needle shield remover. In an exemplaryembodiment, this decrease in the force may be sensed by a user orautomatically by an assembly machine to determine that the capengagement mechanisms have been successfully engaged to the distal cap.In an exemplary embodiment, the engagement of the cap engagementmechanisms with the distal cap may emit an audible “click” sound thatprovides an audible indication that the needle shield remover has beensuccessfully engaged with the distal cap.

FIG. 26 illustrates a device view of the exemplary method 2500 of FIG.25 by which an exemplary automatic injection device may be assembled. Asyringe assembly 2600 may include a syringe, a needle shield remover2602 coupled to the syringe, and a syringe sleeve 2604 coupled to thesyringe and the needle shield remover 2602. A side wall of the syringesleeve 2604 may define or include a transparent inspection window orinspection aperture 2606. The syringe assembly 2600 may be assembledbefore its insertion into a housing 2650 of the automatic injectiondevice. The housing 2650 may have a proximal end 2652 that is openduring assembly and that may be covered by a proximal cap (not pictured)after the syringe assembly is inserted into the housing 2650. Thehousing 2650 may have a distal end 2654 that is open during assembly andthat may be covered by a distal cap (not pictured) after the syringeassembly is inserted into the housing 2650. A side wall of the housing2650 may define or include a transparent inspection window or inspectionaperture 2656 through which a user may view the contents of the syringe.

The assembled syringe 2600 may be inserted into the device housing 2650at the proximal end 2652 in the direction represented by arrow R, sothat the distal end of the needle shield remover 2602 is disposed at thedistal end 2654 of the device housing 2650. Once the syringe assembly2600 is inserted in the housing 2650, the inspection window orinspection aperture 2656 of the housing 2650 is aligned with theinspection window or inspection aperture 2606 of the syringe sleeve2604. The transparent inspection window or inspection aperture 2606 ofthe syringe sleeve 2604 is, in turn, aligned with a cutout portion onthe needle shield remover 2602, thus allowing a user of the device toview the contents of the syringe and/or to view an end-of-injectionindicator through the inspection window or inspection aperture 2656 ofthe device housing 2650.

FIG. 27 is a flowchart of an exemplary method 2700 for assembling anexemplary needle shield remover with a syringe and a distal cap of anautomatic injection device, in which the needle shield remover isassembled with the syringe after insertion of the syringe into thehousing of the device.

In step 2702, a suitable injection needle may be coupled to a distal endof the syringe. In step 2704, a bung may be disposed within the syringeto seal the contents of the syringe. In step 2706, the syringe may befilled with a dose of a therapeutic agent. In step 2708, the injectionneedle may be covered by one or more soft needle shields and/or one ormore rigid needle shields.

In step 2710, in an exemplary embodiment, a syringe sleeve may beengaged to the syringe. The syringe sleeve may be maintained in asubstantially fixed axial orientation relative to the device housing.The syringe sleeve may, in turn, maintain a needle shield remover in asubstantially fixed axial orientation relative to the syringe sleeve.This assembly aligns the cutout portions of the needle shield removerwith the inspection window or inspection aperture of the syringe sleeveand with the inspection window or inspection aperture of the devicehousing. This allows a user to view the contents of the syringe and/orto view an end-of-injection indicator through the inspection window orinspection aperture of the device housing.

In another exemplary embodiment, a syringe sleeve may be absent in theautomatic injection device and step 2710 may be skipped. In thisexemplary embodiment, the axial orientation of the needle shield removermay be manually or automatically adjusted relative to the device housingso that the cutout portions of the needle shield remover are alignedwith the inspection window or inspection aperture of the device housing.This allows a user to view the contents of the syringe and/or to view anend-of-injection indicator through the inspection window or inspectionaperture of the device housing.

In step 2712, the syringe and syringe sleeve assembly may be insertedinto the device housing through a proximal end of the device housing.

In step 2714, a proximal cap may be coupled to the proximal end of thedevice housing to seal the proximal end.

In step 2716, a needle shield remover may be engaged to a distal cap ofthe automatic injection device. In an exemplary embodiment, as thedistal cap is inserted over the needle shield remover, the distal end ofthe needle shield remover may fit within a central aperture provided inthe distal cap. One or more inwardly-projecting stop portions (e.g.,flanges or raised edges) provided in the central aperture of the distalcap may snap into place within a gap formed under the cap engagementmechanisms provided at the distal end of the needle shield remover. Whenthe cap engagement mechanisms snap into place at the gap over theinwardly-projecting stop portions in the central aperture of the distalcap, there may be a decrease in the force experienced against insertionof the distal cap over the needle shield remover. In an exemplaryembodiment, this decrease in the force may be sensed by a user orautomatically by an assembly machine to determine that the capengagement mechanisms have been successfully engaged to the distal cap.In an exemplary embodiment, the engagement of the cap engagementmechanisms with the distal cap may emit an audible “click” sound thatprovides an audible indication that the needle shield remover has beensuccessfully engaged with the distal cap.

In step 2718, the distal cap and needle shield assembly may be coupledto the distal end of the device housing to cover the distal end, so thatthe needle shield remover is engaged to the needle shield on thesyringe. In an exemplary embodiment, one or more inwardly-projectingshield engagement mechanisms of the needle shield remover are engaged toa gap formed between the rigid needle shield and the syringe body. In anexemplary embodiment, as the needle shield remover is inserted over therigid needle shield, the inwardly-projecting shield engagementmechanisms may snap into place at the gap and may not be disengagedduring the assembly process. When the inwardly-projecting shieldengagement mechanisms snap into place at the gap, there may be adecrease in the force experienced against insertion of the needle shieldremover over the rigid needle shield. In an exemplary embodiment, thisdecrease in the force may be sensed by a user or automatically by anassembly machine to determine that the inwardly-projecting shieldengagement mechanisms have been successfully engaged to the needleshield at the gap. In an exemplary embodiment, positioning of the shieldengagement components at the gap may emit an audible “click” sound thatprovides an audible indication that the needle shield remover has beensuccessfully engaged with the rigid needle shield.

In another exemplary embodiment, one or more inwardly-projecting shieldengagement mechanisms of the needle shield remover may be engaged to oneor more apertures defined in a rigid needle shield. In another exemplaryembodiment, one or more inwardly-projecting shield engagement mechanismsof the needle shield remover may engaged to one or more ridged portionsin the exterior surface of the rigid needle shield.

FIG. 28 is a flowchart of an exemplary method 2800 for using anexemplary automatic injection device to administer an injection. Anexemplary automatic injection device may be packaged and pre-filled witha therapeutic agent and may be stored in refrigerated storage beforeuse. In step 2802, the packaged automatic injection device may beremoved from storage. In step 2804, the automatic injection device maybe removed from its packaging and any over-wrap and warmed to roomtemperature, for example, by leaving the device outside the packaging atroom temperature or by warming the device. In step 2806, the user mayview the contents of the device through a transparent inspection windowor inspection aperture provided in the device housing to ensure that thedevice contains a volume of the therapeutic agent and to confirm theclarity of the therapeutic agent, if necessary. In step 2808, theinjection site on a patient's body may be selected and prepared for thedelivery of the therapeutic agent.

In step 2810, the user of the automatic injection device may remove thedistal cap of the automatic injection device that protects the injectionneedle and any needle shields protecting the needle. A needle shieldremover provided in the device automatically removes all of the needleshields when the user removes the distal cap. In step 2812, the user ofthe device may position the automatic injection device so that thedistal end of the device is positioned at or adjacent to the injectionsite on the patient's body. In step 2814, a firing button on the devicemay be depressed or otherwise activated to cause the device to performan injection at the injection site. In step 2816, the injection site onthe patient's body may receive a therapeutically effective dose of thetherapeutic agent administered by the device. In an exemplaryembodiment, activating the firing button may cause a syringe to advancewithin and relative to the device housing so that the injection needleprotrudes from an open distal end of the housing, and may cause a bungto move within the syringe to expel the therapeutic agent out of thesyringe through the injection needle and into the injection site.

In step 2818, after administration of the therapeutic agent, theautomatic injection device may be removed from the injection site on thepatient's body and discarded in an appropriate manner.

IX. INCORPORATION BY REFERENCE

The entire contents of all references, including patents and patentapplications, cited throughout this application are hereby incorporatedherein by reference in their entirety. The appropriate components andmethods of those references may be selected for the invention andembodiments thereof. Still further, the components and methodsidentified in the Background section are integral to this disclosure andmay be used in conjunction with or substituted for components andmethods described elsewhere in the disclosure within the scope of theinvention.

X. EQUIVALENTS

In describing exemplary embodiments, specific terminology is used forthe sake of clarity. For purposes of description, each specific term isintended to, at least, include all technical and functional equivalentsthat operate in a similar manner to accomplish a similar purpose.Additionally, in some instances where a particular exemplary embodimentincludes a plurality of system elements or method steps, those elementsor steps may be replaced with a single element or step. Likewise, asingle element or step may be replaced with a plurality of elements orsteps that serve the same purpose. Further, where parameters for variousproperties are specified herein for exemplary embodiments, thoseparameters may be adjusted up or down by 1/20th, 1/10th, ⅕th, ⅓rd, ½nd,and the like, or by rounded-off approximations thereof, unless otherwisespecified. Moreover, while exemplary embodiments have been shown anddescribed with references to particular embodiments thereof, those ofordinary skill in the art will understand that various substitutions andalterations in form and details may be made therein without departingfrom the scope of the invention. Further still, other aspects, functionsand advantages are also within the scope of the invention.

Exemplary flowcharts are provided herein for illustrative purposes andare non-limiting examples of methods. One of ordinary skill in the artwill recognize that exemplary methods may include more or fewer stepsthan those illustrated in the exemplary flowcharts, and that the stepsin the exemplary flowcharts may be performed in a different order thanshown.

What is claimed is:
 1. An apparatus for removing a needle shield from asyringe, comprising: a tubular member for enclosing the needle shieldcoupled to the syringe; one or more cap engagement mechanisms providedat a distal end of the tubular member and configured for engagement witha distal cap provided for covering a distal end of the syringe; and oneor more shield engagement mechanisms provided at a proximal end of thetubular member and configured for engagement with the needle shield;wherein, when the apparatus is pulled away from the syringe, the one ormore shield engagement mechanisms exert force against the needle shieldto remove the needle shield from the syringe.
 2. The apparatus of claim1, wherein the distal cap comprises an aperture and a flanged portionprovided in the aperture, and wherein the one or more cap engagementmechanisms are configured to fit within the aperture in the distal capand wherein the flanged portion of the distal cap is accommodated in agap under the one or more cap engagement mechanisms.
 3. The apparatus ofclaim 1, wherein the tubular member comprises two apertures, and whereintwo shield engagement mechanisms are provided in the apertures.
 4. Theapparatus of claim 1, wherein the tubular member comprises threeapertures, and wherein three shield engagement mechanisms are providedin the apertures.
 5. The apparatus of claim 1, wherein the one or moreshield engagement mechanisms are configured for engagement with a gapbetween the needle shield and the syringe.
 6. The apparatus of claim 1,wherein the needle shield comprises a soft inner portion and a rigidouter portion.
 7. The apparatus of claim 1, wherein the apparatus isconfigured for engagement with the needle shield coupled to the syringebefore the syringe is inserted into a housing of an automatic injectiondevice.
 8. An automatic injection device, comprising: a syringe; aneedle shield coupled to a distal end of the syringe; a distal cap forcovering the needle shield; and a needle shield remover disposed betweenthe needle shield and the distal cap, the needle shield comprising: atubular member for enclosing the needle shield coupled to the syringe,one or more cap engagement mechanisms provided at a distal end of thetubular member and engaged with the distal cap, and one or more shieldengagement mechanisms provided at a proximal end of the tubular memberand engaged with the needle shield; wherein, when the needle shieldremover is pulled away from the syringe, the one or more shieldengagement mechanisms exert force against the needle shield to removethe needle shield from the syringe.
 9. The automatic injection device ofclaim 8, wherein the distal cap comprises an aperture and a flangedportion provided in the aperture, and wherein the one or more capengagement mechanisms are configured to fit within the aperture in thedistal cap and wherein the flanged portion of the distal cap isaccommodated in a gap under the one or more cap engagement mechanisms.10. The automatic injection device of claim 8, wherein the tubularmember comprises two apertures, and wherein two shield engagementmechanisms are provided in the apertures.
 11. The automatic injectiondevice of claim 8, wherein the tubular member comprises three apertures,and wherein three shield engagement mechanisms are provided in theapertures.
 12. The automatic injection device of claim 8, wherein theone or more shield engagement mechanisms are for engagement with a gapbetween the needle shield and the syringe.
 13. The automatic injectiondevice of claim 8, wherein the needle shield comprises a soft innerportion and a rigid outer portion.
 14. The automatic injection device ofclaim 8, wherein the needle shield remover is configured for engagementwith the needle shield coupled to the syringe before the syringe isinserted into a housing of the automatic injection device.
 15. A methodfor assembling an automatic injection device, comprising: coupling aneedle shield to a distal end of a syringe; engaging one or more shieldengagement mechanisms of a needle shield remover to the needle shield;and inserting an assembly comprising the syringe, the needle shield andthe needle shield remover into a housing of the automatic injectiondevice.
 16. The method of claim 15, further comprising: coupling adistal cap to a distal end of the housing of the automatic injectiondevice; and engaging one or more cap engagement mechanisms of the needleshield remover to the distal cap.
 17. The method of claim 16, furthercomprising: when the needle shield remover is pulled away from thesyringe, exerting force against the needle shield using the shieldengagement mechanisms of the needle shield remover to remove the needleshield from the syringe.
 18. The method of claim 16, wherein the distalcap comprises an aperture and a flanged portion provided in theaperture, and wherein the one or more cap engagement mechanisms areconfigured to fit within the aperture in the distal cap and wherein theflanged portion of the distal cap is accommodated in a gap under the oneor more cap engagement mechanisms.
 19. The method of claim 15, whereinthe needle shield remover comprises a tubular member, and wherein theone or more shield engagement mechanisms are provided at a proximal endof the tubular member and the one or more cap engagement mechanisms areprovided at a distal end of the tubular member.
 20. The method of claim19, wherein the tubular member comprises two apertures, and wherein twoshield engagement mechanisms are provided in the apertures.